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CompletedNCT04104633Updated Jan 13, 2025

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

An interventional study of Blood samples in Breast Cancer and Colo-rectal Cancer, sponsored by Centre Hospitalier Henri Duffaut - Avignon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Centre Hospitalier Henri Duffaut - Avignon · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jun 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Breast Cancer
  • Colo-rectal Cancer

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Keywords

  • ctDNA
  • Molecular karyotype
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In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 18 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Centre Hospitalier Henri Duffaut - Avignon is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Neoadjuvant chemotherapy or neoadjuvant radiotherapy
  • Other cancer
  • BMI > 30
  • Pregnant woman
  • Patients under protective administration or deprived of liberty
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureBlood samples

    30 ml of blood collection

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to surgery

Secondary outcomes

  1. 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

    Time frame: Up to surgery

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Study locations

1 site
  • Centre Hospitalier Henri Duffaut
    Avignon, 84000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04104633
Lead sponsor
Centre Hospitalier Henri Duffaut - Avignon
Responsible party
Sponsor
First posted
Sep 26, 2019
Start date
Jun 14, 2018
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021
Last update
Jan 13, 2025

Study contacts

Guillaume GRANIER, MD
study chair · Centre Hospitalier Henri Duffaut

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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