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NCT Number: NCT05283044

Implementing Precision Medicine in cOmmunity HospiTALs

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de la Côte Basque, Bayonne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biopsy liquid

Biological

Patient performs a blood test at treatment baseline

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Rate of molecular screening failure

    Time frame: 72 months

  3. Relapsed time between liquid biopsy and matched therapy onset

    Time frame: 72 months

  4. 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)

  5. Utilization rate of tumor mutational burden

    Time frame: 72 months

    The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)

  6. Objective Response Rate

    Time frame: 72 months

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Italiano, MD

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Benjamin Verret, MD

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: PRISM-POrTAL

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
Mar 16, 2022
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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