RecruitingNot ApplicableNCT05283044
Implementing Precision Medicine in cOmmunity HospiTALs
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrollment
10,000 participants
Start Date
Jun 29, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- Participants are eligible to be included in the study only if they meet all of the following criteria:
- Age ≥ 18 years
- Histology: solid malignant tumor
- 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)
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Measurable disease as per RECIST criteria
- Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Exclusion Criteria8
- Participants will be excluded from the study if they meet any of the following criteria:
- Radiological evidence of symptomatic or progressive brain metastases
- 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
- 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
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Minors (Age < 18 years)
- Pregnant or breast-feeding women
- Previous enrollment in the present study.
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Interventions
BIOLOGICALbiopsy liquid
Patient performs a blood test at treatment baseline
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT05283044
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