Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer

Resectable Pancreatic Cancer Clinical Trial

— ICAPAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435536
• Other study ID #: RC31/17/0327
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: June 20, 2022

Study information

• Verified date: January 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Kinetic up to one year
Secondary	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)	Kinetic up to one year
Secondary	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)	Kinetic up to one year