Clinical trial NCT02342158: Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors
Official title: Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasm Metastasis
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Cancer Research Center of Marseille
First posted: 2015-01-19
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists
timeFrame: 4-6 weeks after biopsy
Secondary outcomes:
measure: Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing
timeFrame: 3.5 years
measure: Full exome and transcriptome sequencingof locally advanced and metastatic tumours
timeFrame: 6 years
measure: Circulating tumor DNA detection and characterization in locally advanced and metastatic disease
timeFrame: 4 years
measure: Circulating Tumor Cells (CTC) detection and characterization in breast cancer
timeFrame: 3.5 years
measure: Preclinical predictive clinical models validation (limited to breast cancer)
timeFrame: 4 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
References:
citation: 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.
citation: 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.