Implementing Precision Medicine in cOmmunity HospiTALs

Study Overview
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Brief Summary
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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

Detailed Description
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Patients will be selected to present a metastatic cancer (de novo or relapse after primary tumor treatment) eligible for a first line treatment (chemotherapy, immunotherapy, endocrine therapy or targeted therapy). All tumor subtype could be enrolled in the study; metastatic prostate cancer must be resistant to castration. Triple negative breast cancer and Hormone receptor positive, Her2-negative metastatic breast cancer resistant to endocrine therapy are eligible to the study. A plasma sample will be collected at baseline and after the first radiologic assessment after treatment start. Plasma samples obtained at baseline will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Plasma samples obtained during treatment will be tested for the concentration of circulating DNA. Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.

Official Title
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Implementing Precision Medicine in cOmmunity HospiTALs

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Biological: biopsy liquid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Proportion of patients presenting for whom ct DNA sequencing has allowed to propose a systemic treatment that was not considered before by the clinician.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biopsy liquid contributive<br>Patients presenting for whom ct DNA sequencing | Biological: biopsy liquid<br>* Patient performs a blood test at treatment baseline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients for whom ctDNA sequencing | The primary objective of the study will be to evaluate the impact of ctDNA sequencing on the treatment plan of cancer patients managed in satellite centers. This will be performed by estimating the proportion of patients for whom ctDNA sequencing has allowed to propose a systemic treatment that was not considered before the clinician. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization rates of molecular profiling information | The utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies) | 24 months | 
| Rate of molecular screening failure |  | 24 months | 
| Relapsed time between liquid biopsy and matched therapy onset |  | 24 months | 
| Rate of patients presenting targetable alterations | The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions) | 24 months | 
| Utilization rate of tumor mutational burden | The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels) | 24 months | 
| Objective Response Rate |  | 24 months | 
| Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing |  | 24 months |