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

F

Fujian Provincial Hospital

Status

Unknown

Conditions

Bile Duct Neoplasms
Intraductal Papillary Mucinous Neoplasm

Study type

Observational

Funder types

Other

Identifiers

NCT03838913
Fujian Provincial Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

IPNB
Description:
intraductal papillary neoplasm of the bile duct

Trial contacts and locations

1

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Central trial contact

Yaodong Wang, Prof

Data sourced from clinicaltrials.gov

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