UMIN-CTR Clinical Trial

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
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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
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Other related organizations
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IRB Contact (For public release)
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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
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Results Delayed
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Baseline Characteristics
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017159