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Implementing Precision Medicine in cOmmunity HospiTALs (PRISM-POrTAL)

Primary Purpose

Metastatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biopsy liquid
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CH de la Côte BasqueRecruiting
  • CH de BlignyRecruiting
  • CH Sud FrancilienRecruiting
  • CHU de La RéunionRecruiting
  • Hôpital AméricainRecruiting
  • Hôpital Saint-JosephRecruiting
  • Groupement Hospitalier Diaconesses-CroixRecruiting
  • Centre HospitalierRecruiting
  • Centre Eugène MarquisRecruiting
  • HIA BéginRecruiting
  • Hôpital Nord-Ouest Villefranche-sur-SaôneRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Biopsy liquid contributive

Arm Description

Patients presenting for whom ct DNA sequencing

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Rate of molecular screening failure
Relapsed time between liquid biopsy and matched therapy onset
Rate of patients presenting targetable alterations
The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions)
Utilization rate of tumor mutational burden
The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)
Objective Response Rate
Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing

Full Information

First Posted
March 7, 2022
Last Updated
May 17, 2023
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT05283044
Brief Title
Implementing Precision Medicine in cOmmunity HospiTALs
Acronym
PRISM-POrTAL
Official Title
Implementing Precision Medicine in cOmmunity HospiTALs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Roche Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biopsy liquid contributive
Arm Type
Other
Arm Description
Patients presenting for whom ct DNA sequencing
Intervention Type
Biological
Intervention Name(s)
biopsy liquid
Intervention Description
Patient performs a blood test at treatment baseline
Primary Outcome Measure Information:
Title
Proportion of patients for whom ctDNA sequencing
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Utilization rates of molecular profiling information
Description
The utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)
Time Frame
24 months
Title
Rate of molecular screening failure
Time Frame
24 months
Title
Relapsed time between liquid biopsy and matched therapy onset
Time Frame
24 months
Title
Rate of patients presenting targetable alterations
Description
The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions)
Time Frame
24 months
Title
Utilization rate of tumor mutational burden
Description
The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)
Time Frame
24 months
Title
Objective Response Rate
Time Frame
24 months
Title
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
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Verret, MD
Phone
+33 (0)1 42 11 42 11
Email
Benjamin.verret@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Italiano, MD
Phone
+33 (0)1 42 11 42 11
Email
antoine.italiano@gustaveroussy.fr
Facility Information:
Facility Name
CH de la Côte Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Grellety, MD
Email
tgrellety@ch-cotebasque.fr
Facility Name
CH de Bligny
City
Bligny
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Alexande, MD
Email
I.ALEXANDRE@chbligny.fr
Facility Name
CH Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Ezenfis, MD
Email
joel.ezenfis@chsf.fr
Facility Name
CHU de La Réunion
City
La Réunion
ZIP/Postal Code
97448
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed KHETTAB, MD
Email
mohamed.khettab@chu-reunion.fr
Facility Name
Hôpital Américain
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahasti SAGHATCHIAN, Md
Email
mahasti.saghatchian@ahparis.org
Facility Name
Hôpital Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Naltet, MD
Email
cnaltet@ghpsj.fr
Facility Name
Groupement Hospitalier Diaconesses-Croix
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine ANGELERGUES, MD
Email
aangelergues@hopital-dcss.org
Facility Name
Centre Hospitalier
City
Pau
ZIP/Postal Code
64046
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Bourcier, MD
Email
kevin.bourcier@ch-pau.fr
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Massard, MD
Email
c.massard@rennes.unicancer.fr
Facility Name
HIA Bégin
City
Saint-Mandé
ZIP/Postal Code
94160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Hélissey, MD
Phone
+33 (0)1 43 98 51 66
Email
carole.helissey@gmail.com
Facility Name
Hôpital Nord-Ouest Villefranche-sur-Saône
City
Villefranche-sur-Saône
ZIP/Postal Code
69655
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Morel, MD
Email
bomorel@lhopitalnordouest.fr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no IPD in this study

Learn more about this trial

Implementing Precision Medicine in cOmmunity HospiTALs

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