Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

Not Applicable

• Conditions: Neoplasm Metastasis
• Interventions: Procedure: biopsy or surgical sampling; Other: blood sampling

• Registration Number: NCT02342158
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-12
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Primary Completion: 2020-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Locally advanced /metastatic cancer	blood sampling	-
Locally advanced /metastatic cancer	biopsy or surgical sampling	-

Primary Outcome Measures

Name	Time	Method
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists	4-6 weeks after biopsy

Secondary Outcome Measures

Name	Time	Method
Circulating tumor DNA detection and characterization in locally advanced and metastatic disease	4 years
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 Cells (CTC) detection and characterization in breast cancer	3.5 years	Comparison of three distinct methods for the CTC detection in blood
Preclinical predictive clinical models validation (limited to breast cancer)	4 years	Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France