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

NCT06907095 | Recruiting

• 2 other identifiers: 2024-A02283-442023/3648
• Study Type: interventional
• Target: 5,909
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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-cell Carcinomas; Risk of Head and Neck Cancers; Risk of Mesothelioma; Risk of Kidney Cancer; Risk of Prostate Cancer; Risk of Urothelial Cancers; Risk of Endocrine Cancers; Risk of Hematologic Malignancies; Risk of Several Cancer Types; Risk of Neoplasia; Risk of Breast Cancer; Risk of Second Malignancy in Individuals Treated for a Childhood Cancer

Outcome Measures

Primary Outcomes (1)

• sensitivity of techniques derived from body fluids in the detection of any invasive cancer

  The primary endpoint is the sensitivity of body fluid-derived techniques in the detection of any invasive cancer (except for non-melanoma skin cancers) in the 36 months period following body fluid collection among individuals at increased risk of cancer.

  baseline and In case of cancer within 3 years

Secondary Outcomes (3)

• Evaluation of the 3-year early detection performance of techniques derived from body fluids

  baseline and In case of cancer within 3 years

• Evaluation in terms of predicting the risk of developing invasive cancer of the added value at 3 years of body fluid-derived techniques and their various combinations compared with standard baseline factors

  baseline and In case of cancer within 3 years

• Assessment of the ability of body fluid-derived techniques to identify the tissue of origin by agreement between the location predicted by the body fluid-derived techniques and the tissue of origin.

  baseline and In case of cancer within 3 years

Study Arms (2)

individuals at low risk of invasive cancer

ACTIVE COMPARATOR

A cohort of individuals who are not considered at increased risk (low risk) of cancer seen in consultation for a problem defined as benign will also be recruited and be used for certain secondary and exploratory objectives.

Diagnostic Test: biological samples

individuals at high risk of invasive cancer

ACTIVE COMPARATOR

Individuals with an estimated risk ≥ 4% of occurrence of any invasive cancer or malignancy (except for basal cell carcinoma of the skin) in the following three years after inclusion will be proposed the trial. This 4% cumulative risk represents the addition of i. the participant's general risk of any cancer or malignancy based on her/his age and ii. her/his risk of a specific malignancy based on her/his risk profile.

Diagnostic Test: biological samples

Interventions

biological samples DIAGNOSTIC_TEST

biological samples (blood, urine, saliva)

individuals at high risk of invasive cancer; individuals at low risk of invasive cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Suzette Delaloge, MD

  Gustave Roussy, Veillejuif, France

  STUDY CHAIR

Central Study Contacts

Suzette Delaloge, MD

CONTACT

+33 (0)1 42 11 42 11; suzette.delaloge@gustaveroussy.fr

Adeline Salasc, PharmD

CONTACT

+33 (0)1 42 11 42 11; adeline.salasc@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 cohorts: individuals at high risk of invasive cancer and individuals at low risk of invasive cancer

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)