UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049162 |
|---|---|
| Receipt number | R000055999 |
| Scientific Title | A prospective observational study on biliary tract cancer cases undergoing the cancer multi-gene panel testing |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2022/10/07 21:53:02 |
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Basic information
Public title
A prospective observational study on biliary tract cancer cases undergoing the cancer multi-gene panel testing
Acronym
A prospective observational study on biliary tract cancer cases undergoing the cancer multi-gene panel testing
Scientific Title
A prospective observational study on biliary tract cancer cases undergoing the cancer multi-gene panel testing
Scientific Title:Acronym
A prospective observational study on biliary tract cancer cases undergoing the cancer multi-gene panel testing
Region
| Japan |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study focuses on patients diagnosed with locally advanced or metastatic biliary tract cancer or recurrence of the same tumor who have undergone gene panel testing. This study aims to accumulate genetic information from the gene panel test and its clinical data and to clarify its characteristics. This study also seeks to clarify the results of testing, treatment, and prognosis in Japan by summarizing large-scale data obtained from a joint facilities survey.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Disease name: Biliary tract cancer (cases diagnosed histologically or cytologically as biliary tract cancer. For cytological diagnosis, include Class IV)
(2) Stage: All stages are eligible.
Key exclusion criteria
1) Cases in which biliary tract cancer has not been diagnosed histologically or cytologically
(2) Adults who are objectively determined to be incompetent to make adequate decisions
(3) Patients with concurrent active overlapping cancers at the time of enrollment
(4) Other patients deemed inappropriate for the study by the study investigators
(5) Patients for whom it is considered difficult to give valid informed consent.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Unno |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177209
m_unno@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Douchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177209
Homepage URL
d.douchi@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Biliary Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study focuses on patients diagnosed with locally advanced or metastatic biliary tract cancer or recurrence of the same tumor who have undergone gene panel testing.
Management information
Registered date
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055999
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
