Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA

Not Applicable

Completed

• Conditions: Breast Cancer; Colo-rectal Cancer
• Interventions: Procedure: Blood samples

• Registration Number: NCT04104633
• Lead Sponsor: Centre Hospitalier Henri Duffaut - Avignon

Brief Summary

There are several types of circulating DNA: DNA from patient's existing cells, foetal DNA in the case of pregnant woman, and tumoral DNA in the case of patients with cancer. These circulating tumoral DNA (ctDNA) can be obtained from a blood test called liquid biopsy and be detected by the latest generation of very high throughput sequencers with the Massive Parallel Sequencing technique (MPS).

This study focus on using this technique on breast and colorectal cancers in which no analysis of CNV (tumor origin marker) with this technique has been performed yet. It is a prospective, pilot, monocentric, feasibility study on genomic profile. The study aim is to show the possibility to realize in a reproductive way a molecular karyotype on ctDNA with the MPS approach from a liquid biopsy taken from patients with cancer and to compare this profile with the one obtained by CGH array (Comparative Genomic Hybridization) from primitive tumor.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age > 18 years
• Signed consent
• Women with invasive breast carcinoma, NOS, with a radiologically measurable tumor of more than 10 mm (stade I to III)
• Patients with invasive colorectal adenocarcinoma with a radiologically measurable tumor of more than 10 mm (stade I to III)
• Patients who primary surgery is planned

Exclusion Criteria

• Neoadjuvant chemotherapy or neoadjuvant radiotherapy
• Other cancer
• BMI > 30
• Pregnant woman
• Patients under protective administration or deprived of liberty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with breast or colorectal cancer	Blood samples	10 patients with invasive breast carcinoma, not otherwise specified (NOS) (Stade I to III) and 10 patients with invasive colorectal adenocarcinoma (Stade I to III)

Primary Outcome Measures

Name	Time	Method
Feasibility of molecular karyotype performed from liquid biopsy: copies number variations (CNV)	Up to surgery	Feasibility of molecular karyotype showing acquired copies number variations (CNV) on whole genome performed from ctDNA isolated from blood sample in patients with breast or colorectal cancer

Secondary Outcome Measures

Name	Time	Method
Identification of patient's tumor genomic profile with blood sample	Up to surgery	Identification of patient's tumor genomic profile by comparison between genomic profile of primitive tumor obtained by CGH array and genomic profile of ctDNA obtained by Massive Parallel Sequencing

Trial Locations

Locations (1)

Centre Hospitalier Henri Duffaut; 🇫🇷 Avignon, France