Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

Neoplasm Metastasis Clinical Trial

— PERMED01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02342158
• Other study ID #: PERMED01-IPC 2014-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2014
• Est. completion date: November 2022

Study information

• Verified date: January 2021
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: November 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Procedure:
• biopsy or surgical sampling

Other:
• blood sampling

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Cancer Research Center of Marseille

Country where clinical trial is conducted

France, 

Outcome

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