An observational study in Cholangiocarcinoma, sponsored by University of Virginia. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by University of Virginia · Observational
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 A previously performed study pilot study at the University of Virginia (unpublished) showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry, thus showing this is possible.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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 100 is below the median of 196 across 176 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Patients with indeterminate biliary strictures or masses who are already undergoing ERCP with biliary tissue sampling in the form of biliary brushings or biopsies
Exclusion Criteria:
Positive plectin staining on IHC from ERCP-directed biliary samples
Positive plectin staining on IHC from ERCP-directed biliary samples
Time frame: 2 years
Plan to share: No
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University of Virginia