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Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer (ICAPAC)

Primary Purpose

Resectable Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Resectable Pancreatic Cancer focused on measuring circulating tumor DNA, kinetic, pancreatic cancer, pancreatoduodenectomy, Next Generation Sequencing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Circulating tumor DNA

Arm Description

circulating tumor DNA rate at various times of pancreatic cancer resection

Outcomes

Primary Outcome Measures

Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer.
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
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
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)

Full Information

First Posted
February 2, 2018
Last Updated
January 2, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03435536
Brief Title
Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer
Acronym
ICAPAC
Official Title
Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Pancreatic Cancer
Keywords
circulating tumor DNA, kinetic, pancreatic cancer, pancreatoduodenectomy, Next Generation Sequencing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circulating tumor DNA
Arm Type
Experimental
Arm Description
circulating tumor DNA rate at various times of pancreatic cancer resection
Intervention Type
Other
Intervention Name(s)
Blood samples
Intervention Description
Blood samples will be taken to analyze the circulating tumor DNA rate by NGS
Primary Outcome Measure Information:
Title
Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer.
Description
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)
Time Frame
Kinetic up to one year
Secondary Outcome Measure Information:
Title
Overall survival
Description
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)
Time Frame
Kinetic up to one year
Title
Correlation between circulating tumor DNA rate and Ca19.9 dosage
Description
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)
Time Frame
Kinetic up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel CUELLAR, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer

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