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

April 16, 2026 updated by: Institut Paoli-Calmettes

Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • Institut Paoli-Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Locally advanced /metastatic cancer
Other: blood sampling
Procedure: biopsy or surgical sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists
Time Frame: 4-6 weeks after biopsy
4-6 weeks after biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing
Time Frame: 3.5 years
3.5 years
Full exome and transcriptome sequencingof locally advanced and metastatic tumours
Time Frame: 6 years
6 years
Circulating tumor DNA detection and characterization in locally advanced and metastatic disease
Time Frame: 4 years
4 years
Circulating Tumor Cells (CTC) detection and characterization in breast cancer
Time Frame: 3.5 years
Comparison of three distinct methods for the CTC detection in blood
3.5 years
Preclinical predictive clinical models validation (limited to breast cancer)
Time Frame: 4 years
Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

Cancer Research Center of Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2014

Primary Completion (Actual)

August 18, 2022

Study Completion (Actual)

August 18, 2022

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimated)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERMED01-IPC 2014-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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