ADD-ASPIRIN NEWS

August 2017

Add-Aspirin Opens in India!

India Investigator Meeting Feb 2017

The Add-Aspirin Team are delighted to announce that Tata Memorial Hospital in Mumbai, India is now open to recruitment as of 1st August 2017. This has been an ongoing collaboration between TMH and MRC CTU staff who have worked hard to make this a possibility for the trial. In February a number of the Add-Aspirin Team including the Chief Investigator, Professor Ruth Langley and the Director of MRC CTU attended an Add-Aspirin Investigator Meeting in Mumbai to introduce the trial to staff and investigators from across India.

July 2017

Specialist Trainees: Enhance your research portfolio

We have launched a Trainee Programme which will provide specialist medical trainees who have helped with recruitment to the colorectal and gastro-oesophageal cohorts with a certificate for their training portfolio. To find out more information and how to join, please read the Trainee Programme Flyer. If you are interested in signing up, please e-mail the Add-Aspirin mailbox stating your interest: mrcctu.add-aspirin@ucl.ac.uk.

July 2017

Migration of IT Systems now complete: refresh your Internet Explorer settings

For sites experiencing difficulties accessing the Registration and/or Drug Supply Management systems since the systems migration, we recommend proceeding with the following troubleshooting actions:

    • In Internet Explorer, clear the browser history. This will vary a little depending on the browser but should be - “Internet Options”, then “General” tab, click “Delete …” under Browsing History and then “Delete” in the popup window.

    • In Internet Explorer, clear the SSL State. Go to “Internet Options”, then the “Content” tab. Click “Clear SSL State” and then click OK.

    • Restart the computer.


July 2017

Planned Migration of IT Systems

Due to a planned migration of UCL's IT systems some of our systems will not be available on the below dates: This affects the Add-Aspirin website, registration and randomisation systems, the Drug Supply Management System and our online unblinding system.

Tuesday 18th July (all day):

·         The Add-Aspirin main website will be unavailable (http://www.addaspirintrial.org/)

o   Please note online patient registration and drug dispensing will still be available on this date using this link: https://extapps.ctu.mrc.ac.uk/ctux/ and the appropriate login as normal.

o   Phone randomisation line will be open as normal

·         Our out of hours online unblinding system will not be available:

o   For all unblinding requests please call 0207 670 4892 to speak to the trial team or on-call clinician.

Monday 24th  July (From 1pm onwards)  – Tuesday 25th July (all day):

·         Add-Aspirin Online Registration and Telephone Randomisation will be unavailable

  Please arrange for any Registrations and Randomisations to take place either before or after these dates.

·         Drug Supply Management System (IVRS) will be unavailable

To ensure that participants are able to collect drug on these dates, pre-dispensing of trial medication can be completed in advance for follow-up visits, however please do not enter the verification code until the patient has collected their medication.

·         Our out of hours online unblinding system will not be available:

o   For all unblinding requests please call 0207 670 4892 to speak to the trial team or on-call clinician.


No patients can be registered or randomised
from 1pm on Monday 24th July until 9.00am on Wednesday 26th July, and no drug packs can be allocated, verified or amended
during that time.  

Please note that the trial team at MRC CTU will also not have access to these systems on the above dates.


We apologise for the short notice and for any inconvenience caused.

Best wishes,

Add-Aspirin Trial Team


June 2017

Further evidence of the benefits of taking aspirin for people with bowel cancer


A recent report has provided further evidence to suggest that individuals who take aspirin following a diagnosis of colorectal (bowel) cancer are less likely to die from their cancer. The study included 2400 individuals with bowel cancer from Australia, Canada and the U.S. They were asked about the medications they were taking and were followed over a number of years. This was not a clinical trial - a trial is the only way to demonstrate a definite link between aspirin and cancer deaths, and so these findings need to be confirmed.

The researchers reported that, as shown in some other studies of this kind, those individuals who were taking aspirin were less likely to die from their cancer (and less likely to die overall), particularly if they started taking aspirin after their diagnosis.

The researchers also looked at samples of cancer tissue from the participants – their findings suggested that taking aspirin was most likely to be beneficial for individuals whose cancer had a specific genetic make-up (known as “KRAS wild-type”). This is a new finding and needs confirming in other studies. The research was reported in the Journal of Clinical Oncology.

There are some important limitations to this type of study; in particular; there are many other factors that will affect an individual’s risk of dying, and these may differ for those people who did take aspirin and those who did not.  In the Add-Aspirin clinical trial, some participants will take aspirin and others will take a placebo (dummy) tablet    this is decided at random to ensure a fair comparison. Add-Aspirin participants are also being asked to donate samples of their cancer tissue for research that will investigate how aspirin works against cancer and which individuals might benefit the most. This new research further highlights the need for a trial to answer these questions once and for all.

June 2017

BBC News: "Aspirin 'major bleed' warning for over 75s"

This BBC news headline refers to a new study looking at the side effects of aspirin in people of different ages taking it over a number of years. A rare side effect is internal bleeding. This study confirmed that older people (those over 75) are more likely to experience bleeding and showed that it is more likely to be serious in this age group. They also confirmed that, in the under 75s, few people experience bleeding.

The study recruited people who were prescribed aspirin by their GP following a heart attack or stroke. This group includes people who are more likely to experience bleeding with aspirin, such as those with a history of stomach ulcers or kidney failure. These people are not able to take part in the Add-Aspirin trial. Additionally, older people (those aged over 75) joining the trial will not be prescribed the higher dose of aspirin.

When bleeding occurs with aspirin, it is most commonly in the stomach and an additional medication (a proton pump inhibitor, PPI) can be prescribed alongside aspirin to offer some protection against this. However, this is not currently recommended except for specific groups of people who are more likely to experience bleeding. In the Add-Aspirin trial, the study doctor can decide for each individual whether or not to prescribe a PPI, and they may consider this for older patients.

The Oxford study has also highlighted the importance of blood pressure control, since those with high blood pressure are more likely to experience bleeding in the brain. Participants in the Add-Aspirin trial have their blood pressure checked regularly for this reason.

This new research has also confirmed that, particularly for younger people (<75 years), the benefits of taking aspirin following a heart attack or stroke are likely to outweigh the risks of serious side effects. For those taking part in the Add-Aspirin trial, we hope to show combined benefits of aspirin, since it has the potential to both delay cancer recurrence and protect against heart disease. Any participant who is concerned should contact their study doctor.

The study was published in the Lancet journal - the paper can be accessed here.

May 2017

Further research suggests aspirin can reduce risk of breast cancer

A new piece of research has provided further evidence to suggest that individuals who take aspirin have a lower risk of developing breast cancer. Researchers collected information from 57,000 female teachers in California over a period of more than 15 years.

In keeping with previous studies, the researchers found that women who took low dose aspirin (normally defined as 75mg – 100mg) were less likely to develop breast cancer. In particular, they were less likely to develop a common type of breast cancer known as a hormone receptor positive/HER-2 negative cancer.  The findings were reported in the journal Breast Cancer Research and also in the news media  . Previous studies have reported similar findings but some of those studies did not have information about aspirin dose or types of breast cancer. These findings need confirming.

There are some important limitations to this type of study – in particular, there are many other factors that will affect an individual’s risk of developing cancer, and these may differ for those people who did take aspirin and those who did not.

Participants in the Add-Aspirin trial will have had a previous diagnosis and treatment for cancer, and so their risk of cancer returning will be higher than in the general population and they may derive an even greater benefit from taking aspirin. We do not believe that this new information affects the rationale for the trial but we will continue to monitor all new information carefully.

28th April 2017

Add-Aspirin Protocol v5.0 Goes Live


The Add-Aspirin trial office is now fully back up and running following the power outage over Easter, apologies for any inconvenience caused.

All sites who have returned the required amendment documentation should now have received a 'green light' activation email and should work to Add-Aspirin Protocol v5.0 and associated documents.

New version CRFs can be downloaded from the members area and should be used for new and existing patients after 28th April 2017.
Please note, CRF version number does not correspond to protocol version number. 
Participants consented for registration prior to implementation of the amendment on Consent Form v4 should be consented for randomisation on the same form, and no re-consent is required.


April 2017

Easter Closure Dates

Please note the MRCCTU office and randomisation phoneline will be closed on Friday 14th and Monday 17th April and will reopen at 9am on Tuesday 18th April. Please make sure to randomise participants either before or after the Easter weekend. Wales Cancer Bank and Tayside Tissue Bank will also be closed and unable to receive samples on these dates, so please make sure any samples taken prior to Friday 14th are kept locally and refrigerated for posting on Tuesday 18th when the biobanks will re-open.

4th April 2017

Further research suggests aspirin may reduce risk of dying from cancer

Further research has provided more evidence to suggest that individuals who take aspirin have a lower risk of dying from cancer. Researchers looked at data from two very large studies that followed groups of nurses and other healthcare professionals (more than 130,000 people in total) over a period of up to 32 years. These studies were not clinical trials – a trial is the only way to demonstrate a definite link between aspirin and cancer deaths, and so these findings need to be confirmed.

Researchers found that individuals who took aspirin regularly were less likely to die from cancer. In particular, there were fewer deaths from bowel cancer, breast cancer, prostate cancer and lung cancer. The benefits of aspirin were seen in individuals taking low doses of aspirin, such as those used in the Add-Aspirin trial, over a period of several years. These findings were reported at the annual conference of the American Association for Cancer Research.

There are some important limitations to this type of study – in particular, there are many other factors that will affect an individual’s risk of dying from cancer, and these may differ for those people who did take aspirin and those who did not. The study also doesn’t tell us which individuals might benefit the most from taking aspirin – we expect that individuals who have had treatment for a previous cancer may derive the most benefit, but this has not yet been confirmed. The Add-Aspirin trial is designed for this purpose - some participants will take aspirin and others will take a placebo (dummy) tablet – this is decided at random to ensure a fair comparison. This new research further highlights the need for a trial to answer this question once and for all.


24th March 2017

Substantial Amendment: Protocol v5.0 Launch

The Add-Aspirin Trial is pleased to formally notify sites of the Substantial Amendment for Protocol version 5.0 and updated participant materials.

From 24th March 2017 all sites can continue to work to v4.0 of the protocol and supporting documents, but will be expected during the following
4 weeks (deadline 28th April 2017) to complete and submit the amendment documentation (which can be found here) to the Add-Aspirin trial team at mrcctu.add-aspirin@ucl.ac.uk.

Sites who have submitted all of the required documents by the 28th April 2017 will be activated to v5.0 of the protocol and new participant documents. A Green Light e-mail will be sent to confirm all activation requirements have been met.

A temporary suspension to recruitment will be put in place for sites that have not submitted their documentation within this time frame and this will remain until all activation documentation has been received. This means new patients will not be able to be registered on the online system.

Please note, you will still be able to randomise existing recruited patients, however recruitment of new patients will be suspended.

Please contact the Add-Aspirin trial team if you require any assistance with the return of the substantial amendment documentation.

23rd March 2017

Add-Aspirin receives donation from Friends of Cancer Research UK

Friends of CRUK

Lead researcher Professor Ruth Langley was delighted to accept a donation of £45,000 on behalf of CRUK from the Putney, Barnes, Sheen and Kew Group of Friends of Cancer Research UK. This donation was a result of the South West London Christmas Fair fundraising event organised by the group in November 2016.


January 2017

Add-Aspirin reaches 2000 participants!

We are thrilled to have more than 2000 patients registered on Add-Aspirin in the New Year, which reflects the hard work and dedication of site staff over the festive season. 1000 participants have now been registered in the breast cohort, and more than 1400 participants have been randomised overall.

We would like to wish you a very happy new year, and look forward to continuing to work with you in 2017!

December 2016

Christmas & New Year Opening Times

Please note the Randomisation phoneline will be closed from 5pm on 23rd December until 2nd Jan and will reopen at 9am on 3rd January 2017.

There will be limited MRC CTU cover between 28th - 30th December and urgent queries will be prioritised.

The last date for sending translational samples to biobanks will be 21st December 2016.

Wales Cancer Bank will re-open on January 3rd and Tayside Tissue Bank will re-open on January 4th 2017. Any samples taken on 2nd January should be refrigerated until the 3rd when they can be posted to the relevant biobank.

October 2016

Add-Aspirin 1 Year Anniversary - 1000 patients randomised!

October 2016 marks one year since the Add-Aspirin trial opened to recruitment across the UK. Since then 150 hospitals have chosen to participate with the 1000th patient randomised as of 12th October 2016, making it the largest randomised controlled trial to examine the relationship between cancer and aspirin.

Congratulations to to all sites who have contributed to the success of Add-Aspirin across the last year.

August 2016

August Newsletter - 1000th Patient Registered!

On July 15th the 1000th patient was registered to Add-Aspirin. We would like to thank all sites across the UK for your hard work in reaching this milestone in the trial.

For more information please see the August Newsletter in the members area.

June 2016

Self Evident Corrections (SECs)

The Self-evident corrections, or SECs, are specific situations where data given on CRFs will be corrected by the trial team when entered on the database. These are very useful for sites as it means you, the site, will not be notified of these queries, nor will sites need to confirm these corrections.

  • For GCP compliance, the SECs need to be acknowledged and signed off by the overall PI at your site as well as the first point of contact. Once complete, the faxback should be sent to +44 (0)20 7670-4818. Please return the completed faxback document to the Add Aspirin trial team as soon as possible.

Summer 2016

MRC CTU at UCL Joint Urological Trials regional meetings 2016

The MRC CTU at UCL will be hosting four regional Urological Trials meetings to highlight various aspects of urological trials within the Unit, during which there will be a talk from the Add-Aspirin Chief Investigator, Professor Ruth Langley. These meetings are aimed at investigators and research teams at sites. There will be time for discussion and questions, and an opportunity to meet some of the Add-Aspirin team.

We are pleased to announce that booking is now open for the London and Liverpool meetings.

Meetings will be held at:

London - Thursday 16th June (10:00 - 15:10) Henry Wellcome Auditorium
Register here Wellcome Collection
View the agenda 183 Euston Road
London
NW1 2BE

Liverpool - Thursday 30th June (13:00-16:15) BAUS 2016 Annual Scientific Meeting
Register here BT Convention Centre
View the agenda Kings Dock
Waterfront
Liverpool
L3 4FP
Please note that this meeting is also open to people not registered for the BAUS conference.

Bristol - Thursday 7th July Holiday Inn
Register here Bond Street
View the agenda Bristol
BS1 3LE

Glasgow - Monday 12th September Main Senate Room
Register here University of Glasgow
View the agenda University Avenue
Glasgow
G12 8QQ


May 2016

International Clinical Trials Day - Friday 20th May 2016

International Clinical Trials Day took place on 20th May this year. To mark the event, UCL's Institute of Clinical Trials and Methodology held a special half-day event entitled Key Advances in Clinical Trials. This event showcased some of the recent ground-breaking trials activity conducted at the four clinical trials units at UCL. Slides from the event and further information can be found here.

The Add-Aspirin team would like to thank all those taking part in clinical trials.

April 2016

“Daily aspirin recommended in US but still not in Britain”

This headline recently appeared in the Telegraph. The article discusses new recommendations about aspirin use from a group of health officials in the United States (US), and how they differ to those in the United Kingdom (UK). The US recommendations suggest that people aged between 50 and 69 who are known to have a moderate increased risk of heart disease should consider taking daily aspirin to reduce the risk of developing bowel cancer as well as heart and circulatory problems.

This is not the current recommendation in the UK, and doesn’t provide a recommendation for those who have had cancer. The best way to find out more about the health benefits of aspirin is in a clinical trial.

The Add-Aspirin trial is testing whether daily aspirin can prevent cancer returning after cancer treatment, and will also test the other potential health benefits of aspirin including the prevention of heart and circulatory problems. It will also assess whether aspirin help prevent new cancers developing. The results of trials such as Add-Aspirin will help guide health officials on future recommendations about aspirin use.

February 2016

World Cancer Day 2016

To mark World Cancer Day, Cancer Research UK are taking a look at how research that is happening in partnership with other countries is making the future brighter for cancer patients across the globe.

The Add-Aspirin trial, running in the UK, and soon to be India, is looking at whether aspirin can prevent cancer from coming back.

"Every day we see patients who are unable to afford the costs of expensive cancer therapy - they would benefit greatly from in inexpensive form of cancer treatment like aspirin," says Dr Conjeevaram Pramesh, from the Tata Memorial Hospital, Mumbai, leading the Add-Aspirin trial in India. "There is immense potential for a simple, cost-effective treatment like aspirin to help people with Cancer in India and other resource-poor countries."

But importantly, people should not start taking aspirin without first speaking to their doctor, as aspirin isn't suitable for everyone and it can have serious side effects. Please speak to your oncologist or research nurse if you would like to join the Add-Aspirin trial.

Read more here.


September 2015

Guardian: Aspirin 'may double life expectancy of cancer patients'

This headline recently appeared in the Guardian with a number of other newspapers reporting on the same story. The report was about a large study conducted by researchers in the Netherlands. The researchers used national databases to identify people who had been diagnosed with cancer in the digestive system and see whether or not they took aspirin following their diagnosis. They followed this group of nearly 14,000 people over a number of years to see how long they lived after their cancer diagnosis. The results were presented at the European Cancer Congress 2015.

In keeping with other previous studies of this kind, the researchers found that those people who took aspirin were more likely to live longer than those who did not, and that this was particularly notable for people with cancer in the oesophagus (food pipe), colon (large bowel) or rectum. There are some important limitations to this type of study – in particular, there will be many other factors that affect how long a person lives following a cancer diagnosis, and these may differ between those people who did and did not take aspirin. Also, since the information was collected in national databases a number of years ago, it may not be possible to go back and check the details.

The best way to confirm the findings from this and other similar studies is to do a clinical trial. This is the aim of the Add-Aspirin trial. Some participants will take aspirin and others will take a placebo (dummy) tablet – this will be decided at random in order to make a fair comparison. They will be followed up for a number of years to collect all of the relevant information to see whether aspirin can delay or prevent their cancer from returning. This new study further highlights the need for a trial to answer this question once and for all. 

 

September 2015

BBC News: Aspirin 'might boost cancer therapy'

This headline recently appeared on the BBC news, with a number of other newspapers reporting on the same story. The report was about a study in mice by researchers at the Francis Crick Institute. The scientists looked at drugs known as Cox-inhibitors (aspirin is a type of Cox-inhibitor). Their results suggested that using these drugs alongside cancer treatments that are designed to allow the body’s own immune system to attack the cancer may make the treatment more effective. Since this was a study in mice, further research will be needed before it is known whether or not this will be a useful approach in treating people with cancer and which people it might help. The study was published in the journal Cell.

In the Add-Aspirin trial, participants will take aspirin (or a placebo) after initial treatment for cancer for a period of at least 5 years. Aspirin may work in different ways. In the trial, we are mainly trying to find out if aspirin can stop cancers spreading or coming back after initial treatment. The cancer treatments that participants will have received before joining the trial are not the same as those studied in this recent report (as these treatments are not currently used for the types of cancer being studied in the Add-Aspirin trial). We do not believe that this new information affects the rationale for the trial, but it may help us to better understand how aspirin may work against cancer.

 

August 2015

The Times: Daily aspirin found to reduce bowel cancer risk

This headline recently appeared in The Times. It was a report of a large Danish study which has been published in the Annals of Internal Medicine. The researchers looked at cancer registries and data on aspirin prescriptions for more than 10,000 individuals in Denmark. They aimed to see whether taking aspirin affected an individual’s risk of developing bowel cancer. They also looked at use of other non-steroidal anti-inflammatory drugs (NSAIDs), for example, ibuprofen.

 

In keeping with many previous studies, the researchers found that people who took aspirin were less likely to be diagnosed with bowel cancer although, importantly, this only applied to individuals who took aspirin regularly over a long period of time (5 years or more). There are a number of limitations to this type of study – for example, information on other risk factors for developing bowel cancer were not available and may have affected the results. But the results are consistent with previous studies showing that long-term aspirin use appears to reduce the risk of bowel cancer. Participants in the Add-Aspirin trial will have had a previous diagnosis and treatment for cancer, and so their risk of cancer returning will be higher than in the general population and they may derive an even greater benefit from taking aspirin. Participants in the Add-Aspirin trial will be asked to take aspirin (or a placebo) for a period of at least 5 years, so that the effects of long-term use can be seen. We do not believe that this new information affects the rationale for the trial but we will continue to monitor all new information carefully.

June 2015

 

Researchers suggest that people taking aspirin regularly may have a lower risk of cancer

Researchers presenting work at the annual meeting of the American Association for Cancer Research have suggested that people taking aspirin regularly may have a lower risk of cancer.

The American study collected information on aspirin use and cases of cancer over a long period of time in two large groups of people. In keeping with a number of other studies, the results suggested that, overall, individuals who took aspirin regularly were less likely to develop cancer than those who did not take aspirin and that, in particular, they were less likely to develop gastrointestinal (stomach and bowel) cancers. Contrary to some other studies, the findings from this study did not suggest that people taking aspirin were less likely to develop breast, prostate or lung cancers. They also noted that the dose of aspirin may be important. Again, this has not been seen in other studies and needs to be confirmed.
 
Participants in the Add-Aspirin Trial will have had a previous diagnosis and treatment for cancer, and so their risk of cancer returning will be higher than in the general population and they may derive an even greater benefit from taking aspirin. Furthermore, aspirin may work in different ways. In this study the researchers were looking to see if aspirin can stop cancers developing in the first place. In the Add-Aspirin Trial we are mainly trying to find out if aspirin can stop cancers spreading or coming back after initial treatment. We do not believe that this new information affects the rationale for the trial but we will continue to monitor all new information carefully.

May 2015

Daily Telegraph: Aspirin can increase risk of bowel cancer for some, study suggests

An article entitled "Aspirin can increase risk of bowel cancer for some study suggests" recently appeared in the Daily Telegraph. The report referred to an American study, recently published in the Journal of the American Medical Association (JAMA) The study looked at data from 10 previous studies that collected information on use of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) before a diagnosis of bowel cancer was made.

Overall, the researchers found, in keeping with many previous studies, that people who took aspirin and/or other NSAIDs were less likely to be diagnosed with bowel cancer. They also noted that this link may differ according to the genetic make-up of the individual. For a few individuals (only 4% of the group studied with a rare genetic profile) aspirin use was associated with a slightly higher risk of bowel cancer. This is a preliminary finding and will need to be confirmed in other studies. Participants in the Add-Aspirin Trial will have had a previous diagnosis and treatment for cancer, and so their risk of cancer returning will be higher than in the general population and they may derive an even greater benefit from taking aspirin. We do not believe that this new information affects the rationale for the trial but we will continue to monitor all new information carefully.

April 2015

Funding awarded for Add-Aspirin in India

Add-Aspirin collaborators at the Tata Memorial Hospital have been awarded funding from the Sir Dorabji Tata Trust to conduct the trial in India. They are now able to proceed with setting up the trial with the aim of opening in India later this year. Individuals who have had an early stage cancer of the breast, stomach or oesophagus will be able to take part in the trial in India



The trial is being jointly funded by Cancer Research UK (grant number C471 /A15015, www.cancerresearchuk.org), the National Institute for Health Research Health Technology Assessment Programme (project number 12/01/38, www.nihr.ac.uk) and the MRC Clinical Trials Unit at UCL. In India, the Sir Dorabji Tata Trust provides funding.
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