Implementing Precision Medicine in cOmmunity HospiTALs
PRISM-POrTAL
2 other identifiers
interventional
10,000
2 countries
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2030
June 25, 2025
June 1, 2025
6.4 years
March 7, 2022
June 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 (7)
Utilization rates of molecular profiling information
72 months
Rate of molecular screening failure
72 months
Relapsed time between liquid biopsy and matched therapy onset
72 months
Rate of patients presenting targetable alterations
72 months
Utilization rate of tumor mutational burden
72 months
- +2 more secondary outcomes
Study Arms (1)
Biopsy liquid contributive
OTHERPatients presenting for whom ct DNA sequencing
Interventions
Patient performs a blood test at treatment baseline
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
CH de la Côte Basque
Bayonne, 64100, France
CH de Bligny
Bligny, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
CH Sud Francilien
Corbeil-Essonnes, 91106, France
CH Annecy Genevois
Épagny, 74370, France
GHM de Grenoble
Grenoble, 38028, France
CHU de La Réunion
La Réunion, 97448, France
Clinique Saint-Jean l'ermitage
Melun, 77000, France
Hôpital Américain
Neuilly-sur-Seine, 92200, France
Hôpital de la source - CHR d'Orléans
Orléans, 45100, France
Hôpital Saint-Joseph
Paris, 75014, France
Institut Mutualiste Montsouris
Paris, 75014, France
Groupement Hospitalier Diaconesses-Croix
Paris, 75020, France
Centre Hospitalier
Pau, 64046, France
Centre Eugène Marquis
Rennes, 35042, France
Hôpitaux Privés de la Loire
Saint-Etienne, 42100, France
HIA Bégin
Saint-Mandé, 94160, France
Hôpital Foch
Suresnes, 92150, France
Hôpital Nord-Ouest Villefranche-sur-Saône
Villefranche-sur-Saône, 69655, France
CHPF
Pirae, 98716, French Polynesia
Clinique Kuindo Magnin
Noumea, 98800, New Caledonia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2022
First Posted
March 16, 2022
Study Start
June 29, 2022
Primary Completion (Estimated)
November 15, 2028
Study Completion (Estimated)
April 15, 2030
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
no IPD in this study