Implementing Precision Medicine in cOmmunity HospiTALs

Last updated: August 13, 2024
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Metastatic Cancer

Treatment

biopsy liquid

Clinical Study ID

NCT05283044
2021-A02862-39
2021/3331
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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: castrationresistant prostate cancer, for RH+/HER2- breast cancer: prior treatment withendocrine 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 tobiomedical research (Article L.1121-11 of French Public Health Code)

  7. Voluntary signed and dated written informed consent prior to any study specificprocedure.

Exclusion

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, withthe exception of in situ carcinoma of the cervix, and adequately treated basal cellor squamous cell carcinoma of the skin and prostate cancer

  3. Any condition which in the Investigator's opinion makes it undesirable for thesubject to participate in a clinical trial or which would jeopardize compliance withthe protocol

  4. Patient under guardianship or deprived of his liberty by a judicial oradministrative 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.

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: biopsy liquid
Phase:
Study Start date:
June 29, 2022
Estimated Completion Date:
April 15, 2025

Study Description

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.

Connect with a study center

  • CH de la Côte Basque

    Bayonne, 64100
    France

    Active - Recruiting

  • CH de Bligny

    Bligny,
    France

    Active - Recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300
    France

    Site Not Available

  • CH Sud Francilien

    Corbeil-Essonnes, 91106
    France

    Active - Recruiting

  • GHM de Grenoble

    Grenoble, 38028
    France

    Site Not Available

  • CHU de La Réunion

    La Réunion, 97448
    France

    Active - Recruiting

  • Clinique Saint-Jean l'ermitage

    Melun, 77000
    France

    Site Not Available

  • Hôpital Américain

    Neuilly-sur-Seine, 92200
    France

    Active - Recruiting

  • Hôpital de la source - CHR d'Orléans

    Orléans, 45100
    France

    Active - Recruiting

  • Groupement Hospitalier Diaconesses-Croix

    Paris, 75020
    France

    Active - Recruiting

  • Hôpital Saint-Joseph

    Paris, 75014
    France

    Active - Recruiting

  • Institut Mutualiste Montsouris

    Paris, 75014
    France

    Active - Recruiting

  • Centre Hospitalier

    Pau, 64046
    France

    Active - Recruiting

  • Centre Eugène Marquis

    Rennes, 35042
    France

    Active - Recruiting

  • HIA Bégin

    Saint-Mandé, 94160
    France

    Active - Recruiting

  • Hôpitaux Privés de la Loire

    Saint-Étienne, 42100
    France

    Site Not Available

  • Hôpital Nord-Ouest Villefranche-sur-Saône

    Villefranche-sur-Saône, 69655
    France

    Active - Recruiting

  • CH Annecy Genevois

    Épagny, 74370
    France

    Site Not Available

  • CHPF

    Pirae, 98716
    French Polynesia

    Site Not Available

  • Clinique Kuindo Magnin

    Noumea, 98800
    New Caledonia

    Site Not Available

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