UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014767 |
|---|---|
| Receipt number | R000017159 |
| Scientific Title | A prospective observational study investigating clinicopathological and molecular biological features in FGFR2-fusion positive biliary tract cancer |
| Date of disclosure of the study information | 2014/08/05 |
| Last modified on | 2020/02/08 09:01:58 |
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Basic information
Public title
A prospective observational study investigating clinicopathological and molecular biological features in FGFR2-fusion positive biliary tract cancer
Acronym
Prelude trial
Scientific Title
A prospective observational study investigating clinicopathological and molecular biological features in FGFR2-fusion positive biliary tract cancer
Scientific Title:Acronym
Prelude trial
Region
| Japan |
Condition
Condition
bilary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify FGFR2(fibroblast growth factor receptor 2) fusion gene positive biliary tract cancer and to investigate the frequency and clinicopathological and molecular biological features.
Basic objectives2
Others
Basic objectives -Others
biomarker study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of FGFR-fusion gene positive patients in intrahepatic biliary tract cancer
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as intrahepatic bile duct cancer or perihilar bile duct cancer
2) Chemotherapy is underway or preparing for unresectable or recurrent cancer
3) Specimens for genetic analysis are available
4) Written informed consent
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Okusaka Takuji |
Organization
National Cancer Center, Tokyo
Division name
Hepatobiliary and Pancreatic Medical Oncology
Zip code
Address
5-1-1. Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chigusa Morizane |
Organization
National Cancer Center, Tokyo
Division name
Hepatobiliary and Pancreatic Medical Oncology
Zip code
Address
5-1-1. Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL
03-3542-2511
Homepage URL
cmorizan@ncc.go.jp
Sponsor or person
Institute
Exploratory Oncology Research & Clinical Trial Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Division of Cancer Control and Health Promotion, Health Service Bureau,. Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 08 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
2014.8.30 Protocol Amendments ver, 1.3
2014.11.6 IRB approved
2016.11.9 Protocol Amendments ver. 1.4
2016.11.16 IRB approved
Management information
Registered date
| 2014 | Year | 08 | Month | 05 | Day |
Last modified on
| 2020 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017159
