Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10000 participants
INTERVENTIONAL
2022-06-29
2030-04-15
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Biopsy liquid contributive
Patients presenting for whom ct DNA sequencing
biopsy liquid
Patient performs a blood test at treatment baseline
Interventions
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biopsy liquid
Patient performs a blood test at treatment baseline
Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
Yes
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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CH de la Côte Basque
Bayonne, , France
CH de Bligny
Bligny, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CH Sud Francilien
Corbeil-Essonnes, , France
CH Annecy Genevois
Épagny, , France
GHM de Grenoble
Grenoble, , France
CHU de La Réunion
La Réunion, , France
Clinique Saint-Jean l'ermitage
Melun, , France
Hôpital Américain
Neuilly-sur-Seine, , France
Hôpital de la source - CHR d'Orléans
Orléans, , France
Hôpital Saint-Joseph
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Groupement Hospitalier Diaconesses-Croix
Paris, , France
Centre Hospitalier
Pau, , France
Centre Eugène Marquis
Rennes, , France
Hôpitaux Privés de la Loire
Saint-Etienne, , France
HIA Bégin
Saint-Mandé, , France
Hôpital Foch
Suresnes, , France
Hôpital Nord-Ouest Villefranche-sur-Saône
Villefranche-sur-Saône, , France
CHPF
Pirae, , French Polynesia
Clinique Kuindo Magnin
Noumea, , New Caledonia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021/3331
Identifier Type: OTHER
Identifier Source: secondary_id
2021-A02862-39
Identifier Type: -
Identifier Source: org_study_id
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