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Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals

RecruitingNAAges 18 Years - anyAllGustave Roussy, Cancer Campus, Grand Paris
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 years, or * Women who received chest radiotherapy before age 30 years and currently aged ≥ 25 years, or * Women with an invasive breast cancer risk \> 2.5% over the next 5 years, as defined by risk scores +/- genotyping, and aged ≥ 50 years, or * Individuals identified at increased risk in MyPeBS trial (\> 2.5% over the next five years) (www.mypebs.eu) can be eligible for the study, if aged ≥ 50 years, or 2. Situations at increased risk of gynaecological cancer * Women with a Lynch syndrome - germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, and aged ≥ 30 years, or * Women carrying germline (P) or (LP) variants of BRCA1, BRCA2, PALB2, RAD51C or RAD51D, PTEN genes without prophylactic oophorectomy, aged ≥ 40 years, or POLE and POLD1, and aged \> 30 years; or SMARCA4 or DICER1 and aged \> 18 years or 3. Situations at increased risk of colorectal cancer * Men or women with a Lynch syndrome - germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, APC, POLE, POLD1, BMPR1A, SMAD4 or biallelic MuTYH genes, and aged ≥ 40 years, or * Individuals with an increased risk of colorectal cancer defined by the following criteria and aged ≥ 50 years, or * First-degree relative diagnosed with colorectal cancer before the age of 60 years, or * Two or more 1st degree relatives diagnosed with colorectal cancers at any age, or * Personal history of any colorectal adenoma before the age of 50 years or adenomatous polyps \> 1 cm, villous adenomas, dysplastic adenomas, or ≥ 3 adenomatous polyps after the age of 50 years, or * Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) after the age of 50 years, or 4. Situations at increased risk of upper gastrointestinal cancers * Carriers of an STK11 or CDH1 germline (P) or (LP) variants and aged \> 30, or * Individuals with an increased risk of esophageal adenocarcinoma: Barrett's esophagus with high-grade dysplasia, or 5. Situations at increased risk of hepatic cancers \- Individuals at increased risk of hepatocellular carcinoma because of documented liver fibrosis or cirrhosis (whether secondary to non-alcoholic steatohepatitis, alcohol-related, or virus-related), or 6. Situations at increased risk for pancreatic cancers * Patients with a family history with \> 2 pancreatic cancers in close relatives and aged \>50 or * Chronic pancreatitis and aged \>50 or carriers of PRSS1 or SPINK1 germline (P) or (LP) variants or * Patients at increased risk of pancreatic cancer based on a composite score or * Carriers of CDKN2A germline (P) or (LP) variants or * Carriers of germine (P) or (LP) variants in BRCA2, ATM, BRCA1, PALB2, or Lynch syndrome-associated gene alterations with a first-degree or multiple family history of pancreatic ductal carcinoma (PDAC) or * Patients with a Peutz-Jeghers syndrome (STK11 germline (P) or (LP) variants) or 7. Situations at increased risk of lung cancer \- History of heavy smoking \> 20 pack-years among active or previous smokers who have quitted up to 10 years ago, and aged ≥ 50 years, or 8. Situations at increased risk of skin cancers except basal-cell carcinomas * Carriers of germline (P) or (LP) variants in CDKN2A/CDK4 or BAP1 genes, aged ≥ 50 years or * Carriers of germline (P) or (LP) variants of genes that predispose to skin cancers (Xeroderma pigmentosum, etc…) or 9. Situations at increased risk of head and neck cancers * Individuals with high-grade dysplasia or carcinoma in situ of the upper aero digestive tract within the last 10 years, and aged ≥ 50 years, or * Individuals with oral lichen planus diagnosed more than 10 years ago, and aged ≥ 50 years or * Previous history of a head and neck cancer in complete remission for ≥ 5 years, aged ≥ 50 years, and at least one of the following criteria: Current or former smoker \> 10 pack-years Current or former alcohol consumption \> 14 units/week 10. Situations at increased risk of mesothelioma \- Individuals with a history of relevant professional exposure to asbestos, and/or germline (P) or (LP) variants in BAP1, and aged ≥ 50 years, or 11. Situations at increased risk of kidney cancer \- Carriers of germline (P) or (LP) variants in the BAP1, VHL, FH, cMET, FLCN, SDH-B genes, and aged ≥ 50 years, or 12. Situations at increased risk of prostate cancer * Men aged ≥ 40 year with any of the following: * Strong family history: a first- or second-degree relative with metastatic prostate cancer, ovarian cancer, male breast cancer, female breast cancer aged ≤ 45 years, colorectal or endometrial cancer aged ≤ 50 years, pancreatic cancer or two or more first- or second-degree relatives with breast, prostate (but not clinically localized grade group 1), colorectal or endometrial cancer at any age, or * Carriers of germline (P) or (LP) variants in BRCA1, BRCA2, ATM, HOXB13, hMLH1, MSH2, hMLH6, and PMS2, and aged \> 45 13. Situations at increased risk of urothelial cancers * History of heavy smoking \> 30 pack-years,
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What it tests

  • biological samples
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Where

1 site
Gustave Roussy
Villejuif, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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