CompletedNCT03284684Periop ctDNAUpdated Dec 1, 2025

Kinetics of Perioperative Circulating DNA in Cancer Surgery

An observational study in Breast Cancer, Prostate Cancer and Colon Cancer, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 3 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 30
Ages: 18 Years to 75 Years
Sex: All

Study summary

The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery.

Conditions studied

Breast Cancer
Prostate Cancer
Colon Cancer

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Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.

Inclusion criteria

The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
The patient is aged between 18-75
Patient must weigh >40kg
The patient will receive adjusted carcinological surgery
Indication of curative surgery
The patient has already undergone tumoral biopsy prior to surgery
The patient has stage M0 cancer of either colon (right or left colonic adenocarcinoma), prostate (adenocarcinoma) or breast (infiltrating carcinoma)

Exclusion criteria

Exclusion Criteria:

The subject is in a period of exclusion determined by a previous study
The patient is under safeguard of justice
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is pregnant, parturient or breast feeding
Chronic alcoholism
The patient has received radiotherapy or chemotherapy periopratively
Cancer other than colon, breast or prostate
The patient has currently or in the past, had a cancerous lesion
Neo-adjuvant therapy (immunotherapy, radiotherapy, chemotherapy)
Emergency cancer surgery

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 30 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

circulating DNA plasma level test
Other: Blood test

Interventions

OtherBlood test
plasma concentration of circulating DNA of specific genes

What researchers measure

Primary outcomes

Change in concentration of total mutant circulating DNA
ng/mL in plasma
Time frame: Nine timepoints between Day-1 to Day 3
Change in proportion of mutant circulating DNA
ng/mL in plasma
Time frame: Nine timepoints between Day-1 to Day 3
Change in integrity index of circulating DNA for ACTB gene
concentration of long ACTB ctDNA fragments/concentration of short ACTB ctDNA fragments
Time frame: Nine timepoints between Day-1 to Day 3
Change in integrity index of circulating DNA for KRAS gene
concentration of long KRAS ctDNA fragments/concentration of short KRAS ctDNA fragments
Time frame: Nine timepoints between Day-1 to Day 3

Secondary outcomes

Change in plasma concentration of long (~ 290bp) fragments of ACTB gene
ng/mL in plasma
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of short (~ 145bp) fragments of KRAS gene
ng/mL in plasma
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of long (~ 300bp) fragments of KRAS gene
ng/mL in plasma
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of mutant KRAS DNA fragments
ng/mL in plasma
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of BRAF DNA fragments with V600E mutation
ng/mL in plasma
Time frame: Nine timepoints between Day-1 to Day 3

Study locations

3 sites

CHU Montpellier
Montpellier, 34295, France
Institut de Cancérologie Montpellier
Montpellier, 34298, France
CHU Nimes
Nîmes, 30029, France

References and documents

Publications

Kudriavtsev A, Pastor B, Mirandola A, Pisareva E, Gricourt Y, Capdevila X, Thierry AR, Cuvillon P. Association of the immediate perioperative dynamics of circulating DNA levels and neutrophil extracellular traps formation in cancer patients. Precis Clin Med. 2024 Mar 27;7(2):pbae008. doi: 10.1093/pcmedi/pbae008. eCollection 2024 Jun. PubMed 38699382 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03284684
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Responsible party: Sponsor
First posted: Sep 15, 2017
Start date: Jan 22, 2018
Primary completion: Nov 11, 2018
Completion: Nov 11, 2018
Last update: Dec 1, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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