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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Colo-rectal Cancer

Intervention / Treatment
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* Procedure: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with breast or colorectal cancer<br>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<br>* 30 ml of blood collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of patient's tumor genomic profile with blood sample | 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 | Up to surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ctDNA, Molecular karyotype