Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals (NCT06907095) | Clinical Trial Compass
RecruitingNot Applicable
Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals
France5,909 participantsStarted 2026-03-16
Plain-language summary
LEAH is a prospective, observational, single-centre, non-randomised, open-label study of people at increased risk of cancer or malignant disease.
The main objective of LEAH is to evaluate and compare the sensitivity of different tests on body fluids to detect cancers that will occur within 3 years of inclusion in the study, in a cohort of individuals identified as being at increased risk of cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Are aged 18 or more
✓. Have a cumulative 3-year risk of developing any cancer ≥ 4% (including the situation specific cancers + other cancers) defined as follows:
✓. Situations at increased risk of breast cancer
✓. Situations at increased risk of gynaecological cancer
✓. Situations at increased risk of colorectal cancer
✓. Situations at increased risk of upper gastrointestinal cancers
✓. Situations at increased risk of hepatic cancers
✓. Situations at increased risk for pancreatic cancers
Exclusion criteria
✕. Known prior diagnosis of cancer or hematological malignancy within the past 5 years except for non-melanoma skin cancers, in situ cervical cancers and for patients with germline TP53 alterations,
✕. Presence of signs or symptoms of cancer at enrolment,
✕. Acute exacerbation of an autoimmune condition requiring escalation in medical therapy within 14 days prior to enrolment,
✕. Any medical condition with a high likelihood of mortality within three years,
✕. Physical or psychological conditions considered not to be compatible with the study and not likely to comply with follow up requirements,
What they're measuring
1
sensitivity of techniques derived from body fluids in the detection of any invasive cancer
Timeframe: baseline and In case of cancer within 3 years
✕. Individuals under guardianship or deprived of their liberty by a judicial or administrative decision or incapable of giving their consent,
✕. Women carriers of (P) or (LP) variants in BRCA1, BRCA2, PALB2, gene considering prophylactic mastectomy in a near future or aged less than 40 years (since their absolute risk of cancer is lower than the expected threshold)
✕. Received a blood transfusion within the last week before inclusion.