Implementing Precision Medicine in cOmmunity HospiTALs

Обзор

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

Подробное описание

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 will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.

Вмешательства

• Биопрепарат biopsy liquid
  Patient performs a blood test at treatment baseline

Первичные конечные точки

• Proportion of patients for whom ctDNA sequencing [Срок оценки: 72 months]

Вторичные конечные точки (7)

• Utilization rates of molecular profiling information [Срок оценки: 72 months]
• Rate of molecular screening failure [Срок оценки: 72 months]
• Relapsed time between liquid biopsy and matched therapy onset [Срок оценки: 72 months]
• Rate of patients presenting targetable alterations [Срок оценки: 72 months]
• Utilization rate of tumor mutational burden [Срок оценки: 72 months]
• Objective Response Rate [Срок оценки: 72 months]
• Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing [Срок оценки: 72 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 19 центров

• CH de la Côte Basque — Bayonne
• CH de Bligny — Bligny
• Polyclinique Bordeaux Nord Aquitaine — Bordeaux
• CH Sud Francilien — Corbeil-Essonnes
• CH Annecy Genevois — Épagny
• GHM de Grenoble — Grenoble
• CHU de La Réunion — La Réunion
• Clinique Saint-Jean l'ermitage — Melun
• … и ещё 11 центров

French Polynesia · 1 центр

• CHPF — Pirae

New Caledonia · 1 центр

• Clinique Kuindo Magnin — Noumea

Идентификаторы

NCT: NCT05283044 · 2021-A02862-39 · 2021/3331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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