Proteomic Profiling to Differentiate Pancreatic and Biliary Adenocarcinomas (PROFIPANC-CHOL)

Distal cholangiocarcinoma and pancreatic adenocarcinoma are aggressive cancers with overlapping diagnostic features, making them challenging to differentiate. Although both require similar surgical treatment, their postoperative chemotherapy regimens differ significantly, with capecitabine used for distal cholangiocarcinoma and modified FOLFIRINOX for pancreatic adenocarcinoma, based on distinct guidelines. In 10-20% of cases, due to their close anatomical proximity, pathologists cannot distinguish between these cancers, leading to diagnostic uncertainty and potential therapeutic missteps. Proteomic profiling, a cutting-edge technique leveraging protein analysis for diagnostic precision, could offer a novel solution to this challenge, although it has yet to be applied in this context

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Diagnostic test: proteomic profiling

Detailed Description

Distal cholangiocarcinoma (also known as biliary adenocarcinoma) and pancreatic adenocarcinoma are two aggressive cancers with numerous diagnostic similarities. They often present with nearly identical clinical features, tumor markers, and imaging findings on computed tomography (CT). Both cancers require similar surgical management-namely, a pancreaticoduodenectomy (also known as the Whipple procedure)-but their adjuvant systemic chemotherapy protocols in the postoperative setting differ significantly.

According to the French guidelines from the National Digestive Cancer Thesaurus, patients operated on for distal cholangiocarcinoma receive capecitabine as adjuvant therapy, while those treated for pancreatic adenocarcinoma receive modified FOLFIRINOX. These recommendations are based on randomized prospective studies that demonstrated improved overall survival and recurrence-free survival with these specific therapeutic regimens for each cancer. Thus, selecting the appropriate chemotherapy tailored to the cancer type is crucial for patient outcomes.

However, due to the close anatomical proximity of these two tumors-since the bile duct traverses the pancreatic head-it is estimated that in 10-20% of cases, the pathologist is unable to distinguish between these cancers. In such instances, the diagnosis is reported as "adenocarcinoma of pancreatobiliary origin." This ambiguity forces clinicians to choose a chemotherapy regimen based on a combination of clinical, radiological, and pathological findings rather than definitive histological evidence, thereby increasing the risk of an inappropriate treatment choice.

Proteomic profiling is an innovative analytical technique that enables diagnostic insights by analyzing the complete protein composition of a tissue sample and matching it to predefined profiles using statistical algorithms. While this method has already been successfully employed to aid in the diagnosis of other conditions-such as hepatocellular adenomas, amyloidosis, and biliary strictures of indeterminate origin-it has not yet been applied to differentiate pancreatic adenocarcinoma from distal cholangiocarcinoma.

• Study Type: Observational
• Enrollment (Estimated): 28

Contacts and Locations

Study Locations

• France
  • Pessac, France
    • Chu Bordeaux
    • Contact: Arthur Marichez, MD; Email: arthur.marichez@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

10 patients with pancreatic adenocarcinomas, 10 patients with distal cholangiocarcinomas, 8 patients presenting pancreatobiliary adenocarcinomas with diagnostic challenges

Description

Inclusion Criteria:

• Patients ≥ 18 years old
• Pancreaticoduodenectomy for pancreatic adenocarcinoma or distal cholangiocarcinoma
• Patient's non-opposition to the reuse of data

Exclusion Criteria:

• Neoadjuvant chemotherapy
• Patients under legal protection

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pancreatic adenocarcinomas; Patients with pancreatic adenocarcinomas	Diagnostic test: proteomic profiling; proteomic profiling
distal cholangiocarcinomas; Patients with distal cholangiocarcinomas	Diagnostic test: proteomic profiling; proteomic profiling
pancreatobiliary adenocarcinomas with diagnostic challenges; Patients with pancreatobiliary adenocarcinomas with diagnostic challenges	Diagnostic test: proteomic profiling; proteomic profiling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proteomic signature	proteomic signature capable of differentiating cholangiocarcinoma from pancreatic adenocarcinoma through proteomic profiling of surgical specimens	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic biomarkers	diagnostic biomarkers applicable in immunohistochemistry to differentiate cholangiocarcinoma from pancreatic adenocarcinoma based on proteomic analyses	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: University of Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Diagnosis; Pancreatic adenocarcinoma; Proteomic; Proteomic profiling; Biliary adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: CHUBX 2024/94

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No