Kinetics of Perioperative Circulating DNA in Cancer Surgery (Periop ctDNA)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Prostate Cancer; Colon Cancer
• Intervention / Treatment: Other: Blood test

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
circulating DNA plasma level test	Other: Blood test; plasma concentration of circulating DNA of specific genes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): November 11, 2018
• Study Completion (Actual): November 11, 2018

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: NIMAO/2016/PC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No