Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals
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 s
| Condition(s) | Risk of Breast Cancer, Risk of Gynaecological Cancer, Risk of Colorectal Cancer, Risk of Upper Gastrointestinal Cancers, Risk of Hepatic Cancers, Risk of Lung Cancer, Risk of Skin Cancers Except Basal |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria increased risk cohort: 1. Are aged 18 or more 2. Have a cumulative 3-year risk of developing any cancer ≥ 4% (including the situation specific cancers + other cancers) defined as follows: 1. Situations at increased risk of breast cancer * Women carrying germline pathogenic (P) or likely pathogenic (LP) variants of BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 genes without prophylactic mastectomy, aged ≥ 40 years, or * Men with germline (P) or (LP) variants in the BRCA2 gene, aged ≥ 40 years, or * Women with a personal history of an histological atypical breast lesion in the past 5 years and aged ≥ 50 years, or * Women with a personal history of unilateral breast cancer (including ductal carcinoma in situ) diagnosed more than 5 years before inclusion, and currently aged ≥ 60 yea |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Locations | Villejuif, France |
| Start date | 2026-03-16 |
| NCT ID | NCT06907095 |
| Official listing | https://clinicaltrials.gov/study/NCT06907095 |