UMIN-CTR Clinical Trial

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
Email	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
Email	d.douchi@surg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine, Department of Surgery
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055999