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

• Sponsor: Centre Hospitalier Henri Duffaut - Avignon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04104633
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.6
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Colo-rectal Cancer	Procedure: Blood samples	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA
• Actual Study Start Date: Jun 14, 2018
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with breast or colorectal cancer 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; 30 ml of blood collection

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Henri Duffaut	Avignon		France	84000

Sponsors and Collaborators

• Centre Hospitalier Henri Duffaut - Avignon

Investigators

• Study Chair: Guillaume GRANIER, MD, Centre Hospitalier Henri Duffaut

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Henri Duffaut - Avignon
• ClinicalTrials.gov Identifier: NCT04104633
• Other Study ID Numbers: DEGENCA
• First Posted: Sep 26, 2019
• Last Update Posted: Jan 11, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Henri Duffaut - Avignon: ctDNA; Molecular karyotype
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jan 11, 2021