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

ConditionsRisk of Breast CancerRisk of Gynaecological CancerRisk of Colorectal CancerRisk of Upper Gastrointestinal CancersRisk of Hepatic CancersRisk of Lung CancerRisk of Skin Cancers Except Basal-cell CarcinomasRisk of Head and Neck CancersRisk of MesotheliomaRisk of Kidney CancerRisk of Prostate CancerRisk of Urothelial CancersRisk of Endocrine CancersRisk of Hematologic MalignanciesRisk of Several Cancer TypesRisk of Second Malignancy in Individuals Treated for a Childhood CancerRisk of Neoplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are aged 18 or more

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

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • biological samples

    Diagnostic test

    biological samples (blood, urine, saliva)

Treatment groups

5,909 Participants
are divided into 2 treatment groups
Group A: individuals at low risk of invasive cancerActive comparator 1 intervention
Group B: individuals at high risk of invasive cancerActive comparator 1 intervention

Trial outcomes

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.

Time frame
baseline and In case of cancer within 3 years

Secondary outcomes

1

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

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.

Time frame
baseline and In case of cancer within 3 years
2

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

Time frame
baseline and In case of cancer within 3 years
3

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.

Time frame
baseline and In case of cancer within 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

Source ClinicalTrials.gov
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