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

NCT03838913 | Unknown DMC

• 1 other identifier: Fujian Provincial Hospital
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct Neoplasms; Intraductal Papillary Mucinous Neoplasm

Keywords

Whole-exome Sequencing; intraductal papillary neoplasms of the bile duct; mutation characteristics

Outcome Measures

Primary Outcomes (3)

• 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

• Validation of WES outcomes

  To precise determination of mutation signature of WES results by Sanger Sequencing.

  1 year

• Determination of involved signal pathways

  To predict and verify the involved signal pathways by bioinformatics

  1 year

Study Arms (1)

IPNB

intraductal papillary neoplasm of the bile duct

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 cases

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of hepatic mucinous cystadenoma (MCN)
• Complicated with other Malignancy
• Pregnancy

Sponsors & Collaborators

• Fujian Provincial Hospital: lead
• Fujian Medical University Union Hospital: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (1)

Yaodong Wang

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Yaodong Wang, Prof

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaodong Wang, Prof

CONTACT

18105010560; nanfangg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dept. Hepatobiliary Surgery

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: February 12, 2019
• Study Start: February 15, 2019
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)