Whole-Exome Sequencing (WES) of Intraductal Neoplasms of the Bile Duct (IPNB)

Bile Duct Neoplasms Clinical Trial

— WESIPNB  

Official title:

Classification of Mutation Characteristics by Whole-Exome Sequencing (WES) in Intraductal Neoplasms of the Bile Duct (IPNB) Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03838913
• Other study ID #: Fujian Provincial Hospital
• Status: Not yet recruiting
• Start date: February 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: Fujian Provincial Hospital
• Contact: Yaodong Wang, Prof
• Phone: 18105010560
• Email: nanfangg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Using production-scale platform, this study will carry out whole exome sequencing from archival (FFPE) material to Identification and classification of significantly mutated genes, determine the somatic genomic alterations that may be relevant to the development or treatment of cancer, establish classification of IPNBs gene mutation signature. Next, analysis of gene mutation signature and IPNBs clinicopathologic outcomes, including the association between pathologic type, long-term oncological outcomes and gene mutation signature. Last, the determination of involved signal pathways at IPNB patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Intraductal Papillary Mucinous Neoplasm
• Neoplasms

Locations

Country	Name	City	State
China	Yaodong Wang	Fuzhou	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
Fujian Provincial Hospital	First Affiliated Hospital of Fujian Medical University, Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of novel genetic contributors to IPNBs	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.	1 year
Primary	Validation of WES outcomes	To precise determination of mutation signature of WES results by Sanger Sequencing.	1 year
Primary	Determination of involved signal pathways	To predict and verify the involved signal pathways by bioinformatics	1 year