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

Not Applicable

Not yet recruiting

• Conditions: Risk of Breast 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 Gynaecological Cancer; Risk of Kidney Cancer

• Registration Number: NCT06907095
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Status Verified: 2025-04
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Start: 2025-06
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5909

Inclusion Criteria

Not provided

Exclusion Criteria

1. 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,
2. Presence of signs or symptoms of cancer at enrolment,
3. Acute exacerbation of an autoimmune condition requiring escalation in medical therapy within 14 days prior to enrolment,
4. Any medical condition with a high likelihood of mortality within three years,
5. Physical or psychological conditions considered not to be compatible with the study and not likely to comply with follow up requirements,
6. Individuals under guardianship or deprived of their liberty by a judicial or administrative decision or incapable of giving their consent,
7. 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)
8. Received a blood transfusion within the last week before inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
sensitivity of techniques derived from body fluids in the detection of any invasive cancer	baseline and In case of cancer within 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the 3-year early detection performance of techniques derived from body fluids	baseline and In case of cancer within 3 years	for different evaluation criteria: \< stage 2 cancer, any invasive cancer (SO.1, SO.2 and SO.3). These performances will be evaluated in individuals at increased risk of cancer and in subgroups of individuals with several cancer-specific risk situations, using standard performance indices (sensitivity, specificity, precision, negative/positive predictive value, accuracy, etc.) corrected for censoring.
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

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France