Clinical trial NCT03284684: Kinetics of Perioperative Circulating DNA in Cancer Surgery
Official title: Kinetics of Perioperative Circulating DNA in Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Colon Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.

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.


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

Primary outcomes:
measure: Change in concentration of total mutant circulating DNA
timeFrame: Nine timepoints between Day-1 to Day 3
measure: Change in proportion of mutant circulating DNA
timeFrame: Nine timepoints between Day-1 to Day 3
measure: Change in integrity index of circulating DNA for ACTB gene
timeFrame: Nine timepoints between Day-1 to Day 3
measure: Change in integrity index of circulating DNA for KRAS gene
timeFrame: Nine timepoints between Day-1 to Day 3
Secondary outcomes:
measure: Change in plasma concentration of long (~ 290bp) fragments of ACTB gene
timeFrame: Nine timepoints between Day-1 to Day 3
measure: Change in plasma concentration of short (~ 145bp) fragments of KRAS gene
timeFrame: Nine timepoints between Day-1 to Day 3
measure: Change in plasma concentration of long (~ 300bp) fragments of KRAS gene
timeFrame: Nine timepoints between Day-1 to Day 3
measure: Change in plasma concentration of mutant KRAS DNA fragments
timeFrame: Nine timepoints between Day-1 to Day 3
measure: Change in plasma concentration of BRAF DNA fragments with V600E mutation
timeFrame: Nine timepoints between Day-1 to Day 3
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
city: Montpellier
country: France
facility: Institut de Cancérologie Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References: