Implementing Precision Medicine in cOmmunity HospiTALs

2021-A02862-39

This is a prospective biomarker study that aims at demonstrating the impact of liquid biopsy to deliver better treatment for cancer patients with metastatic disease managed in the community setting

2022-06-29

2024-11-15

2025-04-15

Recruiting

1500

Inclusion Criteria: Participants are eligible to be included in the study only if they meet all of the following criteria: 1. Age ≥ 18 years 2. Histology: solid malignant tumor 3. Locally advanced/unresectable and/or metastatic (for prostate cancer: castration resistant prostate cancer, for RH+/HER2- breast cancer: prior treatment with endocrine therapy plus anti-CDK4/6 inhibitor) 4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 5. Measurable disease as per RECIST criteria 6. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code) 7. Voluntary signed and dated written informed consent prior to any study specific procedure. Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. Radiological evidence of symptomatic or progressive brain metastases 2. Previous or current malignancies of others histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer 3. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol 4. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent 5. Minors (Age \< 18 years) 6. Pregnant or breast-feeding women 7. Previous enrollment in the present study.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Proportion of patients presenting for whom ct DNA sequencing has allowed to propose a systemic treatment that was not considered before by the clinician.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}

2024-08-14