Risk of Breast CancerLEAHNCT06907095
Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals
A study testing biological samples in people with Risk of Breast Cancer and Risk of Gynaecological Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk of Breast Cancer, Risk of Gynaecological Cancer, Risk of Colorectal Cancer
- What is being tested?
- biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,909 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2026to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, 94800
Suzette Delaloge, MD, +33 (0)1 42 11 42 11, suzette.delaloge@gustaveroussy.fr
Adeline Salasc, PharmD, +33 (0)1 42 11 42 11, adeline.salasc@gustaveroussy.fr
About this study
Official title: A Prospective Cohort to Evaluate the Ability of Different Body fLuid-derived Approaches to Detect EArly-stage Cancers Among High-risk Individuals
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 Breast Cancer, Risk of Gynaecological Cancer, Risk of Colorectal Cancer, Risk of Upper Gastrointestinal Cancers, Risk of Hepatic Cancers, Risk of Lung Cancer
- Being tested
- biological samples
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplesDiagnostic test
biological samples (blood, urine, saliva)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: baseline and In case of cancer within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start16 Mar 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 cohorts: individuals at high risk of invasive cancer and individuals at low risk of invasive cancer
- Masking
- None (open label)
- Enrolment
- 5,909 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzette Delaloge, MD, Study chair, Gustave Roussy, Veillejuif, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907095
- Sponsor's protocol ID
- 2024-A02283-44
- Other IDs
- 2023/3648
- Acronym
- LEAH
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort to Evaluate the Ability of Different Body fLuid-derived Approaches to Detect EArly-stage Cancers Among High-risk Individuals
- ClinicalTrials.gov ID
- NCT06907095
- Acronym / sponsor ID
- LEAH / 2024-A02283-44
- Conditions
- Risk of Breast Cancer, Risk of Gynaecological Cancer, Risk of Colorectal Cancer, Risk of Upper Gastrointestinal Cancers, Risk of Hepatic Cancers, Risk of Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,909 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 cohorts: individuals at high risk of invasive cancer and individuals at low risk of invasive cancer
| Arm | Type | Receives |
|---|---|---|
| individuals at low risk of invasive cancer | Active comparator | Diagnostic Test: biological samplesA 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. |
| individuals at high risk of invasive cancer | Active comparator | Diagnostic Test: biological samplesIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (86 listed)
- 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:
- Current or former smoker > 10 pack-years Current or former alcohol consumption > 14 units/week
- Beyond the situations described previously, the following individuals are also eligible for LEAH:
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samplesbiological samples (blood, urine, saliva) | Diagnostic test | individuals at high risk of invasive cancer, individuals at low risk of invasive cancer |
Primary outcome
sensitivity of techniques derived from body fluids in the detection of any invasive cancer
Time frame: 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.
3 secondary outcomes
Evaluation of the 3-year early detection performance of techniques derived from body fluids
Time frame: 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
Time frame: 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.
Time frame: baseline and In case of cancer within 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzette Delaloge, MD study chair
Gustave Roussy, Veillejuif, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological samples in people with Risk of Breast Cancer and Risk of Gynaecological Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 86 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzette Delaloge, MD (+33 (0)1 42 11 42 11, suzette.delaloge@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of techniques derived from body fluids in the detection of any invasive cancer (time frame: baseline and In case of cancer within 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.