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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284684
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : January 24, 2019
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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