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Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Gustave Roussy, Cancer Campus, Grand Paris

Conditions:

Risk of Breast Cancer

Risk of Gynaecological Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • Inclusion Criteria increased risk cohort:
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Situations at increased risk of urothelial cancers
  • History of heavy smoking \> 30 pack-years, among active or previous smokers who have quitted up to 10 years ago, and aged ≥ 50 years, or
  • Lynch syndrome with a germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, and aged ≥ 40 years, or
  • Situations at increased risk of endocrine cancers
  • Increased risk of pheochromocytoma paraganglioma in individuals with germline (P) or (LP) variants in RET, VHL, SDHB, SDHD, and aged ≥ 35 years, or
  • Multiple endocrine neoplasia syndrome in individuals with germline (P) or (LP) variants in RET or MEN1, and aged ≥ 40 years, or
  • Situations at increased risk of hematologic malignancies
  • Individuals aged ≥ 50 years with any of the following:
  • Clonal hematopoiesis of indeterminate potential, or
  • Aplastic anemia, or
  • Predisposing genetic alterations (P) or (LP) variants in GATA2, RUNX1, ANKRD26, ETV6, TP53, CEBPA, or DDX41 genes, or copy number variation of chromosome 14q32 region (CNVdup14), or
  • Patients who received high doses of platinum or other compounds who are estimated to have a \> 2% risk of secondary hematological malignancies at 3 years, or
  • Situations at increased risk of several cancer types
  • Germline deleterious mutations of TP53 (Li-Fraumeni syndrome), and aged \> 18 or
  • Germline deleterious (P) or (LP) variants in PTEN, Cowden syndrome, and other PTEN-opathies, aged ≥ 30 years, or
  • Personal history of allogenic organ transplantation at least five years before the inclusion, with long-term ongoing immunosuppressive treatment, and aged ≥ 50 years, or
  • Chronic HIV carriers aged \> 50, or
  • Situations at increased risk of second malignancy in individuals treated for a childhood cancer
  • Brain radiation therapy during childhood, and aged ≥ 18 years, or
  • Childhood malignancy which required chemotherapy and/or radiation therapy, and aged ≥ 40 years, or
  • Beyond the situations described previously, the following individuals are also eligible for LEAH:
  • Increased risk of neoplasia linked to an underlying professional exposure, with a specific cancer risk estimated to be at least 2 % at 3 years, and aged ≥ 50 years, or
  • Other situation: Any particular situation with accumulation of several risk factors likely to induce cancer with a specific risk of cancer estimated at least 2% at 3 years.
  • Participants with a personal cancer or hematological malignancy history are allowed if they are in complete remission at least 5 years from the primary diagnosis
  • All participants must understand spoken and written French language,
  • All participants must agree to comply with the protocol requirements,
  • All participants must understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
  • All participants must be able to access internet through their telephone or a computer
  • Inclusion criteria, control group
  • Individuals seen for a rapid diagnostic procedure at the center as part of the Instadiag programme, that led to a diagnosis of a benign condition
  • Who do not have a high risk situation as defined previously
  • Agree to participate
  • Aged \>18
  • They must understand spoken and written French language,
  • They must agree to comply with the protocol requirements,
  • They must understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
  • They must be able to access internet through their telephone or a computer
  • 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,
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2030

    Estimated Enrollment :

    5909 Patients enrolled

    Trial Details

    Trial ID

    NCT06907095

    Start Date

    June 1 2025

    End Date

    June 1 2030

    Last Update

    April 13 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Gustave Roussy

    Villejuif, France, 94800