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

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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

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.

Condition or disease Intervention/treatment
Breast Cancer Prostate Cancer Colon Cancer Other: Blood test

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Kinetics of Perioperative Circulating DNA in Cancer Surgery
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : November 11, 2018
Actual Study Completion Date : November 11, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in concentration of total mutant circulating DNA [ Time Frame: Nine timepoints between Day-1 to Day 3 ]
    ng/mL in plasma

  2. Change in proportion of mutant circulating DNA [ Time Frame: Nine timepoints between Day-1 to Day 3 ]
    ng/mL in plasma

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Change in plasma concentration of mutant KRAS DNA fragments [ Time Frame: Nine timepoints between Day-1 to Day 3 ]
    ng/mL in plasma

  5. 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


Biospecimen Retention:   Samples With DNA
Blood samples


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284684


Locations
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France
CHU Montpellier
Montpellier, France, 34295
Institut de Cancérologie Montpellier
Montpellier, France, 34298
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03284684    
Other Study ID Numbers: NIMAO/2016/PC-01
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms by Site
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases