Implementing Precision Medicine in cOmmunity HospiTALs | NCT05283044

Studies
Implementing Precision Medicine in cOmmunity HospiTALs

NCT05283044

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Recruiting

Last Update Posted

Jun 25, 2025Actual

Enrollment

10,000Estimated

Phase

Not Applicable

Conditions

Metastatic Cancer

Interventions

biopsy liquid

Countries

France
French Polynesia
New Caledonia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021/3331	Other Identifier	CSET number

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2022Actual

Primary Completion Date

Nov 15, 2028Estimated

Completion Date

Apr 15, 2030Estimated

First Submitted Date

Mar 7, 2022

First Submission Date that Met QC Criteria

Mar 7, 2022

First Posted Date

Mar 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2025

Last Update Posted Date

Jun 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Label	Type	Description	Intervention Names
Biopsy liquid contributive	Other	Patients presenting for whom ct DNA sequencing	Biological: biopsy liquid

Name	Type	Description	Arm Group Labels	Other Names
biopsy liquid	Biological	Patient performs a blood test at treatment baseline	Biopsy liquid contributive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	72 months

Secondary Outcomes

Measure	Description	Time Frame
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)	72 months
Rate of molecular screening failure

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Benjamin Verret, MD	Contact	+33 (0)1 42 11 42 11		Benjamin.verret@gustaveroussy.fr
Antoine Italiano, MD	Contact	+33 (0)1 42 11 42 11		antoine.italiano@gustaveroussy.fr

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques