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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03838913
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Fujian Medical University Union Hospital
First Affiliated Hospital of Fujian Medical University
Information provided by (Responsible Party):
Yaodong Wang, Fujian Provincial Hospital

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.

Condition or disease
Bile Duct Neoplasms Intraductal Papillary Mucinous Neoplasm

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Classification of Mutation Characteristics by Whole-Exome Sequencing (WES) in Intraductal Neoplasms of the Bile Duct (IPNB) Patients
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

intraductal papillary neoplasm of the bile duct

Primary Outcome Measures :
  1. 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.

  2. Validation of WES outcomes [ Time Frame: 1 year ]
    To precise determination of mutation signature of WES results by Sanger Sequencing.

  3. Determination of involved signal pathways [ Time Frame: 1 year ]
    To predict and verify the involved signal pathways by bioinformatics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 cases

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03838913

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Contact: Yaodong Wang, Prof 18105010560 ext 18105010560

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China, Fujian
Yaodong Wang Recruiting
Fuzhou, Fujian, China, 350001
Contact: Yaodong Wang    18105010560 ext 18105010560   
Sponsors and Collaborators
Fujian Provincial Hospital
Fujian Medical University Union Hospital
First Affiliated Hospital of Fujian Medical University
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Principal Investigator: Yaodong Wang, Prof Fujian Provincial Hospital

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Responsible Party: Yaodong Wang, Director of Dept. Hepatobiliary Surgery, Fujian Provincial Hospital Identifier: NCT03838913     History of Changes
Other Study ID Numbers: Fujian Provincial Hospital
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yaodong Wang, Fujian Provincial Hospital:
Whole-exome Sequencing
intraductal papillary neoplasms of the bile duct
mutation characteristics

Additional relevant MeSH terms:
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Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases