Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer

Not Applicable

Completed

• Conditions: Resectable Pancreatic Cancer
• Interventions: Other: Blood samples

• Registration Number: NCT03435536
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Pancreatic cancer represents the fourth cause of death by cancer in western countries. The only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in pancreatic cancer. The purpose of this study is to determine if the pancreatic tumor mobilization during its resection impacts the quantity of circulating tumor DNA in peripheral and portal blood.

Detailed Description

The investigators will analyze if the tumor mobilization increases circulating DNA rate in peripheral and portal blood. Moreover, circulating tumor DNA will be measured during 12 months after surgery in peripheral blood. They will use a gene mutation detection technique called Next Generation Sequencing (NGS) which is more specific than a simple Polymerase Chain Reaction (PCR).

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-19
• Study Start: 2018-02-26
• Primary Completion: 2022-06-20
• Study Completion: 2022-06-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Every patient taken care by Toulouse University Hospital for the resection of a non-metastatic pancreatic adenocarcinoma by whipple resection.
• Patient aged over 18 years old
• Patient having given his written consent
• Patient with social insurance coverage

Exclusion Criteria

• Patients who had surgery, but their pathological examination of the resected specimen does not contain adenocarcinoma.
• Patient for whom the surgery was not realized (exploratory laparotomy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Circulating tumor DNA	Blood samples	circulating tumor DNA rate at various times of pancreatic cancer resection

Primary Outcome Measures

Name	Time	Method
Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer.	Kinetic up to one year	To analyse circulating tumor DNA rate in the portal vein and in peripheral blood at various times of pancreatic cancer resection. Kinetic to 1 day before surgery, during surgery and after surgery (1 day, 10days , one month, 3 months, 6 months and one year after surgery)

Secondary Outcome Measures

Name	Time	Method
Overall survival	Kinetic up to one year	to analyse correlation between circulating tumor DNA rate and overall survival and survival without recurrence. Kinetic to 1 day before surgery, during surgery and after surgery (1 day, one month, 3 months, 6 months and one year after surgery)
Correlation between circulating tumor DNA rate and Ca19.9 dosage	Kinetic up to one year	to analyse correlation between circulating tumor DNA and Ca19.9 rate after dosage of C19.9. Kinetic to 1 day before surgery, and after surgery (on day, one month, 3 months, 6 months and one year after surgery)

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France