Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04104633
Enrollment
18
Registered
2019-09-26
Start date
2018-06-14
Completion date
2021-06-01
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colo-rectal Cancer

Keywords

ctDNA, Molecular karyotype

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.

Interventions

PROCEDUREBlood samples

30 ml of blood collection

Sponsors

Centre Hospitalier Henri Duffaut - Avignon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of molecular karyotype performed from liquid biopsy: copies number variations (CNV)Up to surgeryFeasibility 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

MeasureTime frameDescription
Identification of patient's tumor genomic profile with blood sampleUp to surgeryIdentification 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026