Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples

ClinicalTrials.gov ID: NCT06651346

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Cholangiocarcinoma is a malignancy that is most-often diagnosed with ERCP-directed cytology brushings of the biliary tree, but the yield on this cytology has been previously shown to only be 5%-40%. Additionally, the vast majority (approximately 80%) of patients are not diagnosed until they are surgically unresectable (due to late stage at time of diagnosis), at which point there is no chance for cure and their only options are palliative. Therefore, better diagnostic modalities are needed. Plectin is a structural protein located inside of most cells, but it has been shown to be expressed on the cell surface of malignant cells in the pancreaticobiliary tract. The investigators hypothesize that ERCP-guided biliary samples can provide cells and immunohistochemical staining can detect cell surface plectin in patients with cholangiocarcinoma. This would be a novel diagnostic tool which could greatly reduce the time to diagnosis. A previously performed study pilot study at the University of Virginia (unpublished) showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry, thus showing this is possible. In this current study, patients with a biliary stricture or tumor who are already undergoing ERCP as part of their routine clinical care (i.e. no procedures will be done exclusively for this research study) will undergo an additional biopsy and/or brushing to be assessed for cell-surface plectin expression via immunohistochemistry. The investigators hypothesize that plectin immunohistochemistry will have a higher sensitivity for cholangiocarcinoma than biopsies and/or brushings (cytology) alone.

Study identification

NCT ID: NCT06651346
Recruitment status: Not yet recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: University of Virginia; Other
Enrollment: 100 participants

Conditions and interventions

Conditions

Cholangiocarcinoma

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 1, 2025 (Estimated)
Primary completion: Oct 31, 2026 (Estimated)
Completion: Jan 1, 2027 (Estimated)
Last update posted: Jan 30, 2025

2025 – 2027

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
University of Virginia	Charlottesville	Virginia	22903	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06651346, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 30, 2025 · Synced Nov 15, 2026