Condition category
Cancer
Date applied
14/10/2015
Date assigned
14/10/2015
Last edited
24/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Dr Gillian Borthwick

ORCID ID

Contact details

Institute of Human Genetics
International Centre For Life
Central Parkway
Newcastle Upon Tyne
NE1 3BZ
United Kingdom

Additional identifiers

EudraCT number

2014-000411-14

ClinicalTrials.gov number

Protocol/serial number

17122

Study information

Scientific title

A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3).

Acronym

Study hypothesis

The aim of this study is to find the most effective dose of aspirin to for people with a mismatch repair gene defect, the underlying cause of Lynch syndrome.

Ethics approval

14/NE/0103

Study design

Randomised; Interventional; Design type: Screening, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer, Genetics; Subtopic: All Cancers/Misc Sites, Genetics Research and Congenital Disorders (all subtopics); Disease: All, Genetics Research and Congenital Disorders

Intervention

Participants are asked to take three tablets each day for two years. One tablet will be a placebo, and at least one of the tablets will contain enteric coated aspirin at a dose of either 100mg, 300mg or 600mg. After 2 years on the blinded dose, participants will be given 100mg open label enteric coated aspirin until the last recruit reaches their fifth anniversary. Drug packs will be delivered directly to the patient to save them travelling to collect the drug. They will be routinely followed up by an initial phone call at 3 months and then 6 monthly thereafter for the blinded phase. In the open label phase only yearly follow ups will be required. The aim is to balance adequate safety follow up whilst remaining mindful that patients are not “sick”, so minimising travelling to hospital and being in a clinical environment unnecessarily.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The frequency of Lynch Syndrome Cancers is determined throughout the study and during 10 years following the end of the study.

Secondary outcome measures

Not provided at time of registraiton

Overall trial start date

01/10/2014

Overall trial end date

31/08/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Confirmed germline pathological variant in one of the mismatch repair genes: MSH2, MLH1, PMS2 or MSH6 or a 3’ EPCAM deletion associated with MSH2 silencing or be a carriers of a constitutional epimutation manifesting a classic Lynch syndrome phenotype
3. Able to swallow tablets
4. Willing to complete the CaPP3 consent process as described in the patient information sheet

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 3000; UK Sample Size: 750; Description: As the NHS in the UK are not permitted to sponsor studies overseas, we are encouraging colleagues in other countries to replicate our design exactly which will allow us to pool data. If this is successful we estimate the UK contribution will be 750-1500, with most of the rest coming from EU countries and Australia. All overseas investigatorsrunning parallel studies are responsible for satisfying all their own countries' ethical and regulatory processes.

Participant exclusion criteria

1. Regular use of a non-steroidal anti-inflammatory agent (except aspirin*) on a prescription and/or long-term basis. Regular is defined as > 3 doses per week
2. Regular use of aspirin (> 3 doses per week or on a prescription basis) that cannot be replaced with any one of the randomised arms of the study followed by 100mg dose
3. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma
4. Existing clinically significant liver impairment
5. Existing renal failure
6. Confirmed active peptic ulcer disease within the previous three months
7. Known bleeding diathesis or concomitant anticoagulant therapy
8. Inability to comply with study procedures and agents
9. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years
10. Women who are breastfeeding
11. Any significant medical illness that would interfere with study participation. (If hypertension is discovered, the participant should be advised to have this treated before commencing trial medication)
12. Participation in the previous CAPP2 study will not exclude patients from this study, apart from the small number recruited less than 10 years previously

*Previous use of aspirin for medicinal purposes does not exclude enrollment but duration and quantity need to be documented in detail.

Recruitment start date

01/10/2014

Recruitment end date

31/08/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Human Genetics
International Centre For Life Central Parkway
Newcastle Upon Tyne
NE1 3BZ
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Institute of Genetic Medicine
International Centre for Life
Central Parkway
Newcastle upon Tyne
NE1 3BZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Bayer Pharmaceuticals Plc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes