Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651346
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma From ERCP-directed Biliary Samples
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma From ERCP-directed Biliary Samples
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 We 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 here at UVA by our group showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry thus showing this is possible In this current study we plan to perform patients with a biliary stricture or tumor who are already undergoing ERCP as part of their routine clinical care ie no procedures will be done exclusively for this research study an additional biopsy andor brushing may be obtained to be assessed for cell-surface plectin expression via immunohistochemistry We hypothesize that plectin immunohistochemistry will have a higher sensitivity for cholangiocarcinoma than biopsies andor brushings cytology alone
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None