Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,800

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Lynch Syndrome I (Site-specific Colonic Cancer)
Interventions
DRUG

Aspirin

"Aspirin (acetylsalicylic acid) has a marketing approval for use in the EU and is widely available as an over the counter medicine. However it is not being used within its licensed indication and the aspirin (at any dose in this study) will be treated as an investigational medicinal product (IMP).~Tablets will be provided as enteric-coated 100mg or 300mg tablets for oral use. All patients will receive at least some dose of aspirin but blinding to the actual dose will be achieved by the use of 'dummy' tablets using the same excipients as in the active formulation of the aspirin minus the active ingredient.~The aspirin and dummy tablets should be stored at room temperature below 25⁰C in a dry place."

Trial Locations (1)

64239

Sourasky Medical Center, Tel Aviv

All Listed Sponsors
collaborator

Rambam Health Care Campus

OTHER

collaborator

Rabin Medical Center

OTHER

collaborator

Soroka University Medical Center

OTHER

collaborator

Sheba Medical Center

OTHER_GOV

lead

Tel-Aviv Sourasky Medical Center

OTHER_GOV