Implementing Precision Medicine in cOmmunity HospiTALs

Metastatic Cancer Clinical Trial

— PRISM-POrTAL  

Official title:

Implementing Precision Medicine in cOmmunity HospiTALs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283044
• Other study ID #: 2021-A02862-39
• Secondary ID: 2021/3331
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: April 15, 2025

Study information

• Verified date: May 2023
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Benjamin Verret, MD
• Phone: +33 (0)1 42 11 42 11
• Email: Benjamin.verret[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Biological:
• biopsy liquid
Patient performs a blood test at treatment baseline

Locations

Country	Name	City	State
France	CH de la Côte Basque	Bayonne
France	CH de Bligny	Bligny
France	CH Sud Francilien	Corbeil-Essonnes
France	CHU de La Réunion	La Réunion
France	Hôpital Américain	Neuilly-sur-Seine
France	Groupement Hospitalier Diaconesses-Croix	Paris
France	Hôpital Saint-Joseph	Paris
France	Centre Hospitalier	Pau
France	Centre Eugène Marquis	Rennes
France	HIA Bégin	Saint-Mandé
France	Hôpital Nord-Ouest Villefranche-sur-Saône	Villefranche-sur-Saône

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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)	24 months
Secondary	Rate of molecular screening failure		24 months
Secondary	Relapsed time between liquid biopsy and matched therapy onset		24 months
Secondary	Rate of patients presenting targetable alterations	The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions)	24 months
Secondary	Utilization rate of tumor mutational burden	The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)	24 months
Secondary	Objective Response Rate		24 months
Secondary	Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing		24 months