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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104633
• Other study ID #: DEGENCA
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: June 2021

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Henri Duffaut - Avignon
• Contact: Guillaume GRANIER, MD
• Phone: +33432753270
• Email: ggranier[@]ch-avignon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Blood samples
30 ml of blood collection

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Duffaut	Avignon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Duffaut - Avignon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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