Implementing Precision Medicine in cOmmunity HospiTALs

NCT ID: NCT05283044

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2030-04-15

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 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.

Conditions

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Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Proportion of patients presenting for whom ct DNA sequencing has allowed to propose a systemic treatment that was not considered before by the clinician.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Biopsy liquid contributive

Patients presenting for whom ct DNA sequencing

Group Type OTHER

biopsy liquid

Intervention Type BIOLOGICAL

Patient performs a blood test at treatment baseline

Interventions

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biopsy liquid

Patient performs a blood test at treatment baseline

Intervention Type BIOLOGICAL

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:

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH de la Côte Basque

Bayonne, , France

Site Status RECRUITING

CH de Bligny

Bligny, , France

Site Status RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Site Status ACTIVE_NOT_RECRUITING

CH Sud Francilien

Corbeil-Essonnes, , France

Site Status RECRUITING

CH Annecy Genevois

Épagny, , France

Site Status ACTIVE_NOT_RECRUITING

GHM de Grenoble

Grenoble, , France

Site Status ACTIVE_NOT_RECRUITING

CHU de La Réunion

La Réunion, , France

Site Status RECRUITING

Clinique Saint-Jean l'ermitage

Melun, , France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Américain

Neuilly-sur-Seine, , France

Site Status RECRUITING

Hôpital de la source - CHR d'Orléans

Orléans, , France

Site Status RECRUITING

Hôpital Saint-Joseph

Paris, , France

Site Status RECRUITING

Institut Mutualiste Montsouris

Paris, , France

Site Status RECRUITING

Groupement Hospitalier Diaconesses-Croix

Paris, , France

Site Status RECRUITING

Centre Hospitalier

Pau, , France

Site Status RECRUITING

Centre Eugène Marquis

Rennes, , France

Site Status RECRUITING

Hôpitaux Privés de la Loire

Saint-Etienne, , France

Site Status ACTIVE_NOT_RECRUITING

HIA Bégin

Saint-Mandé, , France

Site Status RECRUITING

Hôpital Foch

Suresnes, , France

Site Status NOT_YET_RECRUITING

Hôpital Nord-Ouest Villefranche-sur-Saône

Villefranche-sur-Saône, , France

Site Status RECRUITING

CHPF

Pirae, , French Polynesia

Site Status ACTIVE_NOT_RECRUITING

Clinique Kuindo Magnin

Noumea, , New Caledonia

Site Status ACTIVE_NOT_RECRUITING

Countries

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France French Polynesia New Caledonia

Central Contacts

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Benjamin Verret, MD

Role: CONTACT

+33 (0)1 42 11 42 11

Antoine Italiano, MD

Role: CONTACT

+33 (0)1 42 11 42 11

Facility Contacts

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Thomas Grellety, MD

Role: primary

Ingrid Alexande, MD

Role: primary

Joel Ezenfis, MD

Role: primary

Mohamed KHETTAB, MD

Role: primary

Mahasti SAGHATCHIAN, Md

Role: primary

Heba DAWOOD, MD, PhD

Role: primary

+33 (2) 38 51 40 87

Charles Naltet, MD

Role: primary

David MALKA, MD, PhD

Role: primary

+33 (1) 56 61 62 63

Antoine ANGELERGUES, MD

Role: primary

Kevin Bourcier, MD

Role: primary

Christophe Massard, MD

Role: primary

Carole Hélissey, MD

Role: primary

+33 (0)1 43 98 51 66

Jaafar BENNOUNA, MD

Role: primary

+33 (0)1 46 25 19 75

Boris Morel, MD

Role: primary

Other Identifiers

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2021/3331

Identifier Type: OTHER

Identifier Source: secondary_id

2021-A02862-39

Identifier Type: -

Identifier Source: org_study_id

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