Kinetics of Perioperative Circulating DNA in Cancer Surgery

NCT03284684 | Completed

• 2 other identifiers: NIMAO/2016/PC-012017-A00950-53
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

Breast Cancer; Prostate Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (4)

• Change in concentration of total mutant circulating DNA

  ng/mL in plasma

  Nine timepoints between Day-1 to Day 3

• Change in proportion of mutant circulating DNA

  ng/mL in plasma

  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

  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

  Nine timepoints between Day-1 to Day 3

Secondary Outcomes (5)

• Change in plasma concentration of long (~ 290bp) fragments of ACTB gene

  Nine timepoints between Day-1 to Day 3

• Change in plasma concentration of short (~ 145bp) fragments of KRAS gene

  Nine timepoints between Day-1 to Day 3

• Change in plasma concentration of long (~ 300bp) fragments of KRAS gene

  Nine timepoints between Day-1 to Day 3

• Change in plasma concentration of mutant KRAS DNA fragments

  Nine timepoints between Day-1 to Day 3

• Change in plasma concentration of BRAF DNA fragments with V600E mutation

  Nine timepoints between Day-1 to Day 3

Study Arms (1)

circulating DNA plasma level test

Other: Blood test

Interventions

Blood test OTHER

plasma concentration of circulating DNA of specific genes

circulating DNA plasma level test

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

CHU Montpellier

Montpellier, 34295, France

Location

Institut de Cancérologie Montpellier

Montpellier, 34298, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 38699382 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colonic Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: September 15, 2017
• Study Start: January 22, 2018
• Primary Completion: November 11, 2018
• Study Completion: November 11, 2018
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)