Clinical trial · Observational
Whole-Exome Sequencing (WES) of Intraductal Neoplasms of the Bile Duct (IPNB)
Classification of Mutation Characteristics by Whole-Exome Sequencing (WES) in Intraductal Neoplasms of the Bile Duct (IPNB) Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Intraductal papillary neoplasm of the bile duct (IPNB) is a distinct type of biliary tumor characterised with delicate fibrovascular stalks (papillary of villous) covered at biliary epithelium. The typical pathologic feature is dramatical dilation of affected bile ducts due to obstruction by mucin production. IPNB has a better prognosis than bile duct carcinoma, but the current proposed entity contains multiple definitions or categories, thus confused in pathology. Although mutations of several genes on IPNBs (such as GNAS, KRAS, APC, CTNNB1, and RNF43) identified in previous studies, there is still an unification at gene expression signature. This research trial will use whole exome sequencing and subsequent bioinformatic analysis in finding causative mutations in deoxyribonucleic acid (DNA) samples from IPNBs patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Neoplasms | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Intraductal Papillary Mucinous Neoplasm | Pancreatic Intraductal Papillary Mucinous Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- IPNB
- description
- intraductal papillary neoplasm of the bile duct
Primary outcomes (3)
- measure
- Identification of novel genetic contributors to IPNBs
- timeFrame
- 1 year
- description
- Novel genetic abnormalities that are found to be associated with IPNBs via production-scale platform for whole exome sequencing from archival (FFPE) material. The tumor and normal specimens will be obtained from patients with IPNBs who are receiving treatment at Fujian Provincial Hospital, Fujian Medical University Union Hospital and First affiliated Hospital of Fujian Medical University.
- measure
- Validation of WES outcomes
- timeFrame
- 1 year
- description
- To precise determination of mutation signature of WES results by Sanger Sequencing.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of IPNBs * ECOG Performance status of 0, 1, or 2 * Adequate liver function, bilirubin \< 1.5 times ULN, ALT or AST \< 2.5 times ULN * Adequate renal function: creatinine \< 1.8 * Must be at least 18 Exclusion Criteria: * Diagnosis of hepatic mucinous cystadenoma (MCN) * Complicated with other Malignancy * Pregnancy
References
Publications (0)
Data not yet available