Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

NCT ID: NCT02342158

Last Updated: 2021-01-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-12

Study Completion Date

2022-11-30

Brief Summary

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PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.

Detailed Description

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Conditions

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Neoplasm Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Locally advanced /metastatic cancer

Group Type EXPERIMENTAL

biopsy or surgical sampling

Intervention Type PROCEDURE

blood sampling

Intervention Type OTHER

Interventions

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biopsy or surgical sampling

Intervention Type PROCEDURE

blood sampling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age\>18 years
* Histological diagnosis of cancer
* Locally advanced or metastatic, biopsiable disease
* ECOG Performans Status ≤2
* Affiliation to social security
* Signed informed consent.

Exclusion Criteria

* Emergency, Individually deprived of liberty or placed under the authority of a tutor
* Patients with symptomatic or progressive brain metastasis
* Patients who have only bone and/or brain metastases
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research Center of Marseille

OTHER

Sponsor Role collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Paoli-Calmettes

Marseille, , France

Site Status

Countries

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France

References

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Sabatier R, Garnier S, Guille A, Carbuccia N, Pakradouni J, Adelaide J, Provansal M, Cappiello M, Rousseau F, Chaffanet M, Birnbaum D, Mamessier E, Goncalves A, Bertucci F. Whole-genome/exome analysis of circulating tumor DNA and comparison to tumor genomics from patients with heavily pre-treated ovarian cancer: subset analysis of the PERMED-01 trial. Front Oncol. 2022 Jul 29;12:946257. doi: 10.3389/fonc.2022.946257. eCollection 2022.

Reference Type DERIVED
PMID: 35965534 (View on PubMed)

Bertucci F, Goncalves A, Guille A, Adelaide J, Garnier S, Carbuccia N, Billon E, Finetti P, Sfumato P, Monneur A, Pecheux C, Khran M, Brunelle S, Mescam L, Thomassin-Piana J, Poizat F, Charafe-Jauffret E, Turrini O, Lambaudie E, Provansal M, Extra JM, Madroszyk A, Gilabert M, Sabatier R, Vicier C, Mamessier E, Chabannon C, Pakradouni J, Viens P, Andre F, Gravis G, Popovici C, Birnbaum D, Chaffanet M. Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial. Genome Med. 2021 May 18;13(1):87. doi: 10.1186/s13073-021-00897-9.

Reference Type DERIVED
PMID: 34006291 (View on PubMed)

Other Identifiers

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PERMED01-IPC 2014-003

Identifier Type: -

Identifier Source: org_study_id

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