ICAPAC: Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT03435536

Collaborator

(none)

Enrollment

Location

Arm

67.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Resectable Pancreatic Cancer	Other: Blood samples	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.

Actual Study Start Date :

Feb 26, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Circulating tumor DNA circulating tumor DNA rate at various times of pancreatic cancer resection	Other: Blood samples Blood samples will be taken to analyze the circulating tumor DNA rate by NGS

Arm

Intervention/Treatment

Experimental: Circulating tumor DNA

circulating tumor DNA rate at various times of pancreatic cancer resection

Other: Blood samples

Blood samples will be taken to analyze the circulating tumor DNA rate by NGS

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)