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

February 11, 2019 updated by: Yaodong Wang, Fujian Provincial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Yaodong Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

60 cases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IPNB
intraductal papillary neoplasm of the bile duct

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of novel genetic contributors to IPNBs
Time Frame: 1 year
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
Time Frame: 1 year
To precise determination of mutation signature of WES results by Sanger Sequencing.
1 year
Determination of involved signal pathways
Time Frame: 1 year
To predict and verify the involved signal pathways by bioinformatics
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Provincial Hospital

Collaborators

First Affiliated Hospital of Fujian Medical University
Fujian Medical University Union Hospital

Investigators

  • Principal Investigator: Yaodong Wang, Prof, Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 15, 2019

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (ACTUAL)

February 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fujian Provincial Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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