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

• ClinicalTrials.gov Identifier: NCT03284684
• Recruitment Status: Completed
• First Posted: September 15, 2017
• Last Update Posted: January 24, 2019
• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nīmes

Tracking Information

• First Submitted Date: August 8, 2017
• First Posted Date: September 15, 2017
• Last Update Posted Date: January 24, 2019
• Actual Study Start Date: January 22, 2018
• Actual Primary Completion Date: November 11, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 12, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Kinetics of Perioperative Circulating DNA in Cancer Surgery
• Official Title: Kinetics of Perioperative Circulating DNA in Cancer Surgery
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood samples

• Sampling Method: Non-Probability Sample
• Study Population: Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.

Condition

• Breast Cancer
• Prostate Cancer
• Colon Cancer

Intervention

Other: Blood test

plasma concentration of circulating DNA of specific genes

Study Groups/Cohorts

circulating DNA plasma level test

Intervention: Other: Blood test

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2017): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 11, 2018
• Actual Primary Completion Date: November 11, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03284684
• Other Study ID Numbers: NIMAO/2016/PC-01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• Study Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Universitaire de Nīmes
• Verification Date: January 2019