Metastatic CancerPRISM-POrTALNCT05283044
Implementing Precision Medicine in cOmmunity HospiTALs
A study testing biopsy liquid in people with Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 21 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- biopsy liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 29 Jun 2022to 15 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 3 countries
France19 sites, 14 recruiting
- Recruiting
CH de la Côte Basque
Bayonne, 64100
Thomas Grellety, MD, tgrellety@ch-cotebasque.fr
- Recruiting
CH de Bligny
Bligny
Ingrid Alexande, MD, I.ALEXANDRE@chbligny.fr
- Active, not recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
- Recruiting
CH Sud Francilien
Corbeil-Essonnes, 91106
Joel Ezenfis, MD, joel.ezenfis@chsf.fr
- Active, not recruiting
CH Annecy Genevois
Épagny, 74370
- Active, not recruiting
GHM de Grenoble
Grenoble, 38028
- Recruiting
CHU de La Réunion
La Réunion, 97448
Mohamed KHETTAB, MD, mohamed.khettab@chu-reunion.fr
- Active, not recruiting
Clinique Saint-Jean l'ermitage
Melun, 77000
- Recruiting
Hôpital Américain
Neuilly-sur-Seine, 92200
Mahasti SAGHATCHIAN, Md, mahasti.saghatchian@ahparis.org
- Recruiting
Hôpital de la source - CHR d'Orléans
Orléans, 45100
Heba DAWOOD, MD, PhD, +33 (2) 38 51 40 87, heba.dawood@chr-orleans.fr
- Recruiting
Hôpital Saint-Joseph
Paris, 75014
Charles Naltet, MD, cnaltet@ghpsj.fr
- Recruiting
Institut Mutualiste Montsouris
Paris, 75014
David MALKA, MD, PhD, +33 (1) 56 61 62 63, david.malka@imm.fr
- Recruiting
Groupement Hospitalier Diaconesses-Croix
Paris, 75020
Antoine ANGELERGUES, MD, aangelergues@hopital-dcss.org
- Recruiting
Centre Hospitalier
Pau, 64046
Kevin Bourcier, MD, kevin.bourcier@ch-pau.fr
- Recruiting
Centre Eugène Marquis
Rennes, 35042
Christophe Massard, MD, c.massard@rennes.unicancer.fr
- Active, not recruiting
Hôpitaux Privés de la Loire
Saint-Etienne, 42100
- Recruiting
HIA Bégin
Saint-Mandé, 94160
Carole Hélissey, MD, +33 (0)1 43 98 51 66, carole.helissey@gmail.com
- Not yet recruiting
Hôpital Foch
Suresnes, 92150
Jaafar BENNOUNA, MD, +33 (0)1 46 25 19 75, j.bennouna@hopital-foch.com
- Recruiting
Hôpital Nord-Ouest Villefranche-sur-Saône
Villefranche-sur-Saône, 69655
Boris Morel, MD, bomorel@lhopitalnordouest.fr
French Polynesia1 site
- Active, not recruiting
CHPF
Pirae, 98716
New Caledonia1 site
- Active, not recruiting
Clinique Kuindo Magnin
Noumea, 98800
About this study
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
Read the 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.
- Conditions
- Metastatic Cancer
- Being tested
- biopsy liquid
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy liquidBiological
Patient performs a blood test at treatment baseline
| Study group | Role | What they receive |
|---|---|---|
| Biopsy liquid contributive | Other | Patients presenting for whom ct DNA sequencing Receives: Biological: biopsy liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 months
Secondary outcomes (7)
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)
Measured: 72 months
Rate of molecular screening failure
Measured: 72 months
Relapsed time between liquid biopsy and matched therapy onset
Measured: 72 months
Rate of patients presenting targetable alterations
The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions)
Measured: 72 months
Utilization rate of tumor mutational burden
The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)
Measured: 72 months
Objective Response Rate
Measured: 72 months
Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start29 Jun 2022
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proportion of patients presenting for whom ct DNA sequencing has allowed to propose a systemic treatment that was not considered before by the clinician.
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283044
- Sponsor's protocol ID
- 2021-A02862-39
- Other IDs
- 2021/3331
- Acronym
- PRISM-POrTAL
- Status last verified
- Jun 2025
- First submitted
- 7 Mar 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD in this study
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Precision Medicine in cOmmunity HospiTALs
- ClinicalTrials.gov ID
- NCT05283044
- Acronym / sponsor ID
- PRISM-POrTAL / 2021-A02862-39
- Conditions
- Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Apr 2030 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proportion of patients presenting for whom ct DNA sequencing has allowed to propose a systemic treatment that was not considered before by the clinician.
| Arm | Type | Receives |
|---|---|---|
| Biopsy liquid contributive | Other | Biological: biopsy liquidPatients presenting for whom ct DNA sequencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy liquidPatient performs a blood test at treatment baseline | Biological | Biopsy liquid contributive |
Primary outcome
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.
7 secondary outcomes
Utilization rates of molecular profiling information
Time frame: 72 months
Rate of molecular screening failure
Time frame: 72 months
Relapsed time between liquid biopsy and matched therapy onset
Time frame: 72 months
Rate of patients presenting targetable alterations
Time frame: 72 months
Utilization rate of tumor mutational burden
Time frame: 72 months
Objective Response Rate
Time frame: 72 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No. no IPD in this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy liquid in people with Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, French Polynesia, New Caledonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Verret, MD (+33 (0)1 42 11 42 11, Benjamin.verret@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients for whom ctDNA sequencing (time frame: 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.