NCT02342158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

7.8 years

First QC Date

December 16, 2014

Last Update Submit

April 16, 2026

Conditions

Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

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

    4-6 weeks after biopsy

Secondary Outcomes (5)

  • Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing

    3.5 years

  • Full exome and transcriptome sequencingof locally advanced and metastatic tumours

    6 years

  • Circulating tumor DNA detection and characterization in locally advanced and metastatic disease

    4 years

  • Circulating Tumor Cells (CTC) detection and characterization in breast cancer

    3.5 years

  • Preclinical predictive clinical models validation (limited to breast cancer)

    4 years

Study Arms (1)

Locally advanced /metastatic cancer

EXPERIMENTAL
Procedure: biopsy or surgical samplingOther: blood sampling

Interventions

biopsy or surgical samplingPROCEDURE
Locally advanced /metastatic cancer
blood samplingOTHER
Locally advanced /metastatic cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Related Publications (2)

  • 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.

    PMID: 34006291RESULT

  • 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.

    PMID: 35965534RESULT

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

BiopsyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesPunctures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 19, 2015

Study Start

November 12, 2014

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)