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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

Primary Purpose

Breast Cancer, Colo-rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
Centre Hospitalier Henri Duffaut - Avignon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring ctDNA, Molecular karyotype

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Henri DuffautRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with breast or colorectal cancer

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2019
Last Updated
January 8, 2021
Sponsor
Centre Hospitalier Henri Duffaut - Avignon
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1. Study Identification

Unique Protocol Identification Number
NCT04104633
Brief Title
Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA
Official Title
Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Duffaut - Avignon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colo-rectal Cancer
Keywords
ctDNA, Molecular karyotype

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with breast or colorectal cancer
Arm Type
Other
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Blood samples
Intervention Description
30 ml of blood collection
Primary Outcome Measure Information:
Title
Feasibility of molecular karyotype performed from liquid biopsy: copies number variations (CNV)
Description
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
Time Frame
Up to surgery
Secondary Outcome Measure Information:
Title
Identification of patient's tumor genomic profile with blood sample
Description
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
Time Frame
Up to surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume GRANIER, MD
Phone
+33432753270
Email
ggranier@ch-avignon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume GRANIER, MD
Organizational Affiliation
Centre Hospitalier Henri Duffaut
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Henri Duffaut
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume GRANIER, MD
Phone
+33432753270
Email
ggranier@ch-avignon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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