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

NCT04104633 | Completed

• 1 other identifier: DEGENCA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colo-rectal Cancer

Keywords

ctDNA; Molecular karyotype

Outcome Measures

Primary Outcomes (1)

• Feasibility of molecular karyotype performed from liquid biopsy: copies number variations (CNV)

  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

  Up to surgery

Secondary Outcomes (1)

• Identification of patient's tumor genomic profile with blood sample

  Up to surgery

Study Arms (1)

Patients with breast or colorectal cancer

OTHER

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)

Procedure: Blood samples

Interventions

Blood samples PROCEDURE

30 ml of blood collection

Patients with breast or colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Henri Duffaut - Avignon: lead

Study Sites (1)

Centre Hospitalier Henri Duffaut

Avignon, 84000, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Guillaume GRANIER, MD

  Centre Hospitalier Henri Duffaut

  STUDY CHAIR

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: September 24, 2019
• First Posted: September 26, 2019
• Study Start: June 14, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)