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

NCT ID: NCT03838913

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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.

Conditions

Bile Duct Neoplasms; Intraductal Papillary Mucinous Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

IPNB

intraductal papillary neoplasm of the bile duct

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yaodong Wang

Director of Dept. Hepatobiliary Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaodong Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Fujian Provincial Hospital

Locations

Yaodong Wang

Fuzhou, Fujian, China

Countries

China

Central Contacts

Yaodong Wang, Prof

Role: CONTACT

nanfangg@gmail.com

18105010560 ext. 18105010560

Facility Contacts

Yaodong Wang

Role: primary

nanfangg@gmail.com

18105010560 ext. 18105010560

Other Identifiers

Fujian Provincial Hospital

Identifier Type: -

Identifier Source: org_study_id