Proteomic Profiling to Differentiate Pancreatic and Biliary Adenocarcinomas

NCT06776146 | Not Yet Recruiting

• 1 other identifier: CHUBX 2024/94
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic adenocarcinoma; Biliary adenocarcinoma; Diagnosis; Proteomic; Proteomic profiling

Outcome Measures

Primary Outcomes (1)

• proteomic signature

  proteomic signature capable of differentiating cholangiocarcinoma from pancreatic adenocarcinoma through proteomic profiling of surgical specimens

  baseline

Secondary Outcomes (1)

• diagnostic biomarkers

  baseline

Study Arms (3)

pancreatic adenocarcinomas

Patients with pancreatic adenocarcinomas

Diagnostic Test: proteomic profiling

distal cholangiocarcinomas

Patients with distal cholangiocarcinomas

Diagnostic Test: proteomic profiling

pancreatobiliary adenocarcinomas with diagnostic challenges

Patients with pancreatobiliary adenocarcinomas with diagnostic challenges

Diagnostic Test: proteomic profiling

Interventions

proteomic profiling DIAGNOSTIC_TEST

proteomic profiling

distal cholangiocarcinomas; pancreatic adenocarcinomas; pancreatobiliary adenocarcinomas with diagnostic challenges

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Neoadjuvant chemotherapy
• Patients under legal protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (1)

CHU Bordeaux

Pessac, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)