Implementing Precision Medicine in cOmmunity HospiTALs (PRISM-POrTAL)

June 20, 2025 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bayonne, France, 64100
      • Bligny, France
      • Bordeaux, France, 33300
        • Active, not recruiting
        • Polyclinique Bordeaux Nord Aquitaine
      • Corbeil-Essonnes, France, 91106
      • Grenoble, France, 38028
        • Active, not recruiting
        • GHM de Grenoble
      • La Réunion, France, 97448
      • Melun, France, 77000
        • Active, not recruiting
        • Clinique Saint-Jean l'ermitage
      • Neuilly-sur-Seine, France, 92200
      • Orléans, France, 45100
        • Recruiting
        • Hôpital de la source - CHR d'Orléans
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Hôpital Saint-Joseph
        • Contact:
      • Paris, France, 75020
      • Pau, France, 64046
      • Rennes, France, 35042
      • Saint-Mandé, France, 94160
      • Saint-Étienne, France, 42100
        • Active, not recruiting
        • Hôpitaux Privés de la Loire
      • Suresnes, France, 92150
      • Villefranche-sur-Saône, France, 69655
      • Épagny, France, 74370
        • Active, not recruiting
        • Ch Annecy Genevois
  • French Polynesia
      • Pirae, French Polynesia, 98716
        • Active, not recruiting
        • CHPF
  • New Caledonia
      • Noumea, New Caledonia, 98800
        • Active, not recruiting
        • Clinique Kuindo Magnin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients for whom ctDNA sequencing
Time Frame: 72 months
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.
72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilization rates of molecular profiling information
Time Frame: 72 months
The utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)
72 months
Rate of molecular screening failure
Time Frame: 72 months
72 months
Relapsed time between liquid biopsy and matched therapy onset
Time Frame: 72 months
72 months
Rate of patients presenting targetable alterations
Time Frame: 72 months
The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions)
72 months
Utilization rate of tumor mutational burden
Time Frame: 72 months
The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)
72 months
Objective Response Rate
Time Frame: 72 months
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
Time Frame: 72 months
72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

Roche Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Estimated)

November 15, 2028

Study Completion (Estimated)

April 15, 2030

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02862-39
  • 2021/3331 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no IPD in this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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