Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer

NCT03435536 | Completed

• 1 other identifier: RC31/17/0327
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Pancreatic Cancer

Keywords

circulating tumor DNA; kinetic; pancreatic cancer; pancreatoduodenectomy; Next Generation Sequencing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

  Kinetic up to one year

• Correlation between circulating tumor DNA rate and Ca19.9 dosage

  Kinetic up to one year

Study Arms (1)

Circulating tumor DNA

EXPERIMENTAL

circulating tumor DNA rate at various times of pancreatic cancer resection

Other: Blood samples

Interventions

Blood samples OTHER

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

Circulating tumor DNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, 31059, France

Location

Related Publications (1)

• Maulat C, Canivet C, Cabarrou B, Pradines A, Selves J, Casanova A, Doussine A, Hanoun N, Cuellar E, Boulard P, Carrere N, Buscail L, Bournet B, Muscari F, Cordelier P. Prognostic impact of circulating tumor DNA detection in portal and peripheral blood in resected pancreatic ductal adenocarcinoma patients. Sci Rep. 2024 Nov 8;14(1):27296. doi: 10.1038/s41598-024-76903-y.

  PMID: 39516243 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emmanuel CUELLAR, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: February 26, 2018
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: November 28, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)