Biliary Tract CancerNCT03718897
Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
An observational study of Biliary Tract Cancer, run by Ji Kon Ryu at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Endoscopic retrograde cholangiopancreatogram
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Sep 2018to 2 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During the study period, all patients who were diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram at Seoul National University Hospital will be enrolled. The investigators will perform whole genome sequencing of biopsy specimens from patients with biliary tract cancer and analyze the gene mutations associated with patient survival. And additionally, the presence or absence of blood circulating tumor DNA and associated gene mutation will be analyzed.
Who may be able to join
- Patients diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram
Who cannot join
- Pregnancy
- Other active tumors within 5 years
- Coagulopathy
- Severe mental illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Min su You, MD, 82-2-2072-2228, bass105@hanmail.net
Ji Kon Ryu, MD, PhD, 82-2-2072-2228, jkryu@snu.ac.kr
About this study
The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.
Read the detailed description
Recently, as genome technology such as next-generation sequencing has progressed, precision medicine using genetic analysis in lung cancer, colorectal cancer, and melanoma has been actively studied. The need for such precision medicine is also increasing in biliary tract cancer patients. Although whole genome sequencing is relatively costly, it is known to provide more accurate information than other methods such as exome analysis and RNA sequencing in identifying promoter mutations, regulatory regions, and structural variants. Pancreatic cancer and melanoma have been studied by whole genome sequencing, but there is no previous study using whole genome sequencing method in biliary tract cancer.
- Conditions
- Biliary Tract Cancer
- Being tested
- Endoscopic retrograde cholangiopancreatogram
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatogramDiagnostic test
Biopsy specimens are attained via endoscopic retrograde cholangiopancreatogram in patients with suspicious biliary tract cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Comparisons of overall survival rates between patients with gene mutations and without.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start14 Sep 2018
- Primary completion2 Sep 2020 (estimated)
- Study completion2 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Kon Ryu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Kon Ryu, Seoul National University Hospital
- Investigators
- Ji Kon Ryu, MD, phD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718897
- Sponsor's protocol ID
- 1808-056-964
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
- ClinicalTrials.gov ID
- NCT03718897
- Acronym / sponsor ID
- 1808-056-964
- Conditions
- Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ji Kon RyuUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 2 Sep 2020 (estimated)
- Study completion
- 2 Sep 2022 (estimated)
- First posted
- 25 Oct 2018 (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.
The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.
Detailed description
Recently, as genome technology such as next-generation sequencing has progressed, precision medicine using genetic analysis in lung cancer, colorectal cancer, and melanoma has been actively studied. The need for such precision medicine is also increasing in biliary tract cancer patients. Although whole genome sequencing is relatively costly, it is known to provide more accurate information than other methods such as exome analysis and RNA sequencing in identifying promoter mutations, regulatory regions, and structural variants. Pancreatic cancer and melanoma have been studied by whole genome sequencing, but there is no previous study using whole genome sequencing method in biliary tract cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During the study period, all patients who were diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram at Seoul National University Hospital will be enrolled. The investigators will perform whole genome sequencing of biopsy specimens from patients with biliary tract cancer and analyze the gene mutations associated with patient survival. And additionally, the presence or absence of blood circulating tumor DNA and associated gene mutation will be analyzed.
Key inclusion criteria (1 listed)
- Patients diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram
Key exclusion criteria (4 listed)
- Pregnancy
- Other active tumors within 5 years
- Coagulopathy
- Severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic retrograde cholangiopancreatogramBiopsy specimens are attained via endoscopic retrograde cholangiopancreatogram in patients with suspicious biliary tract cancer. | Diagnostic test | – |
Primary outcome
Overall survival rate
Time frame: 48 months
Comparisons of overall survival rates between patients with gene mutations and without.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- 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.
Ji Kon Ryu, MD, phD study director
Seoul National University 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 Biliary Tract Cancer, run by Ji Kon Ryu at 1 site in South Korea.
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 1 inclusion and 4 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 25 Oct 2018. 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 South Korea. 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 Min su You, MD (82-2-2072-2228, bass105@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 48 months). 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 25 Oct 2018.