Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT02497820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2016-08-25
First Post:
2015-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaPP3 Israel
Brief Summary:
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).
Detailed Description:
Study design: A randomised, double-blind, dose non-inferiority study.
Study Intervention: Enteric-coated aspirin 100mg, 300mg or 600mg blinded dose daily followed by daily 100mg open label dose daily.
Primary objective: To determine whether the cancer preventive properties of enteric coated aspirin in Lynch syndrome are dose sensitive by comparing overall cumulative Lynch syndrome cancer incidence rates after 5 years in people who took 100mg, 300mg or 600mg enteric coated aspirin for at least 2 years.
Secondary objectives: Compare overall cumulative incidence of primary colorectal cancers using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups.
Compare overall cumulative incidence of primary endometrial cancers using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups.
Compare overall cumulative incidence of cancers of all types, using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups.
The burden of adverse events associated with the different aspirin doses in this relatively young and healthy population will be documented.
Primary outcome: The number of new primary mismatch repair deficient cancers ("Lynch syndrome cancers") at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
Number of study sites: 4 ISRAEL sites. 20 sites all over the world.
Study population/size: 300 patients in ISRAEL. UK 1000-1500 patients. Total with International 3,000 patients.
Study duration: 7 years.
Study Intervention: Enteric-coated aspirin 100mg, 300mg or 600mg blinded dose daily followed by daily 100mg open label dose daily.
Primary objective: To determine whether the cancer preventive properties of enteric coated aspirin in Lynch syndrome are dose sensitive by comparing overall cumulative Lynch syndrome cancer incidence rates after 5 years in people who took 100mg, 300mg or 600mg enteric coated aspirin for at least 2 years.
Secondary objectives: Compare overall cumulative incidence of primary colorectal cancers using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups.
Compare overall cumulative incidence of primary endometrial cancers using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups.
Compare overall cumulative incidence of cancers of all types, using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups.
The burden of adverse events associated with the different aspirin doses in this relatively young and healthy population will be documented.
Primary outcome: The number of new primary mismatch repair deficient cancers ("Lynch syndrome cancers") at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
Number of study sites: 4 ISRAEL sites. 20 sites all over the world.
Study population/size: 300 patients in ISRAEL. UK 1000-1500 patients. Total with International 3,000 patients.
Study duration: 7 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: