Kinetics of Perioperative Circulating DNA in Cancer Surgery

Breast Cancer Clinical Trial

— Periop ctDNA  

Official title:

Kinetics of Perioperative Circulating DNA in Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284684
• Other study ID #: NIMAO/2016/PC-01
• Status: Completed
• Start date: January 22, 2018
• Est. completion date: November 11, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 11, 2018
• Est. primary completion date: November 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Prostate Cancer

Intervention

Other:
• Blood test
plasma concentration of circulating DNA of specific genes

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier
France	Institut de Cancérologie Montpellier	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in concentration of total mutant circulating DNA	ng/mL in plasma	Nine timepoints between Day-1 to Day 3
Primary	Change in proportion of mutant circulating DNA	ng/mL in plasma	Nine timepoints between Day-1 to Day 3
Primary	Change in integrity index of circulating DNA for ACTB gene	concentration of long ACTB ctDNA fragments/concentration of short ACTB ctDNA fragments	Nine timepoints between Day-1 to Day 3
Primary	Change in integrity index of circulating DNA for KRAS gene	concentration of long KRAS ctDNA fragments/concentration of short KRAS ctDNA fragments	Nine timepoints between Day-1 to Day 3
Secondary	Change in plasma concentration of long (~ 290bp) fragments of ACTB gene	ng/mL in plasma	Nine timepoints between Day-1 to Day 3
Secondary	Change in plasma concentration of short (~ 145bp) fragments of KRAS gene	ng/mL in plasma	Nine timepoints between Day-1 to Day 3
Secondary	Change in plasma concentration of long (~ 300bp) fragments of KRAS gene	ng/mL in plasma	Nine timepoints between Day-1 to Day 3
Secondary	Change in plasma concentration of mutant KRAS DNA fragments	ng/mL in plasma	Nine timepoints between Day-1 to Day 3
Secondary	Change in plasma concentration of BRAF DNA fragments with V600E mutation	ng/mL in plasma	Nine timepoints between Day-1 to Day 3