Bile Duct NeoplasmsWESIPNBNCT03838913
Whole-Exome Sequencing (WES) of Intraductal Neoplasms of the Bile Duct (IPNB)
An observational study of Bile Duct Neoplasms and Intraductal Papillary Mucinous Neoplasm, run by Fujian Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bile Duct Neoplasms, Intraductal Papillary Mucinous Neoplasm
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 cases
Who may be able to join
- 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
Who cannot join
- Diagnosis of hepatic mucinous cystadenoma (MCN)
- Complicated with other Malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Yaodong Wang
Fuzhou, Fujian, 350001
Yaodong Wang, 18105010560 ext. 18105010560, nanfangg@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Whole-exome Sequencing, intraductal papillary neoplasms of the bile duct, mutation characteristics
- Medical subject headings
- Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IPNB | intraductal papillary neoplasm of the bile duct |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Validation of WES outcomes
To precise determination of mutation signature of WES results by Sanger Sequencing.
Measured: 1 year
Determination of involved signal pathways
To predict and verify the involved signal pathways by bioinformatics
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start15 Feb 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, First Affiliated Hospital of Fujian Medical University
- Responsible party
- Principal investigator, Yaodong Wang, Fujian Provincial Hospital
- Investigators
- Yaodong Wang, Prof, Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838913
- Sponsor's protocol ID
- Fujian Provincial Hospital
- Acronym
- WESIPNB
- Status last verified
- Feb 2019
- First submitted
- 13 Jan 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Mutation Characteristics by Whole-Exome Sequencing (WES) in Intraductal Neoplasms of the Bile Duct (IPNB) Patients
- ClinicalTrials.gov ID
- NCT03838913
- Acronym / sponsor ID
- WESIPNB / Fujian Provincial Hospital
- Keywords
- Whole-exome Sequencing, intraductal papillary neoplasms of the bile duct, mutation characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, First Affiliated Hospital of Fujian Medical University
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPNB | – | –intraductal papillary neoplasm of the bile duct |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 cases
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of hepatic mucinous cystadenoma (MCN)
- Complicated with other Malignancy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Validation of WES outcomes
Time frame: 1 year
To precise determination of mutation signature of WES results by Sanger Sequencing.
Determination of involved signal pathways
Time frame: 1 year
To predict and verify the involved signal pathways by bioinformatics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaodong Wang, Prof principal investigator
Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Neoplasms and Intraductal Papillary Mucinous Neoplasm, run by Fujian Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaodong Wang, Prof (18105010560 ext. 18105010560, nanfangg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of novel genetic contributors to IPNBs (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.