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NCT06651346 · ClinicalTrials.gov registry record
Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples
A clinical trial, sponsored by University of Virginia.
- Not yet
- Registry status
- 100
- Enrollment target
NCT06651346: Clinical Trial study, sponsored by University of Virginia.
NCT06651346 is a clinical trial that has not yet begun recruiting, run by University of Virginia. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06651346 has not yet begun recruiting, sponsored by University of Virginia.
- NOT YET RECRUITING
- Registry status
- 100 participants
- Enrollment target
Study Summary
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 A previously performed study pilot study at the University of Virginia (unpublished) showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry, thus showing this is possible.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.
Primary Outcome
Positive plectin staining on IHC from ERCP-directed biliary samples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-02-01 |
| Est. Completion | 2027-01-01 |
What is known before NCT06651346 opens enrollment
NCT06651346 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT06651346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06651346 about?
NCT06651346 is a clinical study titled "Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples". 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 surg...
What is the current status of trial NCT06651346?
This trial is currently not yet recruiting. The enrollment target is 100 participants. The study started on 2025-02-01. Estimated completion is 2027-01-01.
Who is sponsoring clinical trial NCT06651346?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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