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Completed

NCT Number: NCT03284684

Kinetics of Perioperative Circulating DNA in Cancer Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Test

Other

plasma concentration of circulating DNA of specific genes

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: Periop ctDNA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2017
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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