search
Back to results

Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors (PERMED01)

Primary Purpose

Neoplasm Metastasis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biopsy or surgical sampling
blood sampling
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neoplasm Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Paoli-Calmettes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Locally advanced /metastatic cancer

Arm Description

Outcomes

Primary Outcome Measures

proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists

Secondary Outcome Measures

Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing
Full exome and transcriptome sequencingof locally advanced and metastatic tumours
Circulating tumor DNA detection and characterization in locally advanced and metastatic disease
Circulating Tumor Cells (CTC) detection and characterization in breast cancer
Comparison of three distinct methods for the CTC detection in blood
Preclinical predictive clinical models validation (limited to breast cancer)
Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro

Full Information

First Posted
December 16, 2014
Last Updated
January 21, 2021
Sponsor
Institut Paoli-Calmettes
Collaborators
Cancer Research Center of Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT02342158
Brief Title
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors
Acronym
PERMED01
Official Title
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2014 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Cancer Research Center of Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Locally advanced /metastatic cancer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
biopsy or surgical sampling
Intervention Type
Other
Intervention Name(s)
blood sampling
Primary Outcome Measure Information:
Title
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists
Time Frame
4-6 weeks after biopsy
Secondary Outcome Measure Information:
Title
Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing
Time Frame
3.5 years
Title
Full exome and transcriptome sequencingof locally advanced and metastatic tumours
Time Frame
6 years
Title
Circulating tumor DNA detection and characterization in locally advanced and metastatic disease
Time Frame
4 years
Title
Circulating Tumor Cells (CTC) detection and characterization in breast cancer
Description
Comparison of three distinct methods for the CTC detection in blood
Time Frame
3.5 years
Title
Preclinical predictive clinical models validation (limited to breast cancer)
Description
Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35965534
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.
Results Reference
derived
PubMed Identifier
34006291
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.
Results Reference
derived

Learn more about this trial

Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

We'll reach out to this number within 24 hrs