Implementing Precision Medicine in cOmmunity HospiTALs (PRISM-POrTAL)

Gustave Roussy

Status: Enrolling

Conditions: Metastatic Cancer

Treatments: Biological: biopsy liquid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05283044

2021/3331 (Other Identifier)

2021-A02862-39

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

Biopsy liquid contributive

Other group

Description:

Patients presenting for whom ct DNA sequencing

Treatment:

Biological: biopsy liquid