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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014767
Receipt No. 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 2019/08/11

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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
Email 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
Email cmorizan@ncc.go.jp

Sponsor
Institute Exploratory Oncology Research & Clinical Trial Center
Institute
Department

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
Email

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 Open public recruiting
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
2019 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017159

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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