UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on prognosis and diagnosis of gallbladder cancer.
Acronym	GALLOP study
Scientific Title	Prospective study on prognosis and diagnosis of gallbladder cancer.
Scientific Title:Acronym	GALLOP study
Region	Japan

Condition
Condition	Gallbladder cancer (Including cystic duct carcinoma)
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	For gallbladder cancer, candidate optimal treatment policies derived from diagnosis time information are clarified by prospective observational research.
Basic objectives2	Others
Basic objectives -Others	In this study, clinical staging is registered at the time of diagnosis of gallbladder cancer, and the subsequent treatment, surgical resection, pathology result, prognosis are analyzed positively. Comparing prognosis and optimal treatment based on the diagnosis at the time of treatment decision can not be searched by retrospective research after grasping the curiosity of prognosis and surgery.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Relapse free survival Adverse event occurrence rate Serious adverse event (adverse reaction) incidence Complication incidence, severity and type of surgery ,chemotherapy, radiation therapy, other treatments The 30-day mortality rate The 90-day mortality rate

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. Conditions diagnosed as gallbladder cancer and cystic duct carcinoma by diagnostic imaging before the commencement of treatment 2. Age at registration is over 20 years old
Key exclusion criteria	1. Patients who can not photograph either contrast CT or simple MRI 2. Patients judged unsuitable as subjects by the attending physician
Target sample size	200

Research contact person
Last 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	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7205
Email	kein_h11@surg1.med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Kei Middle name Last name Nakagawa
Organization	Tohoku University Hospital
Division name	Department of Surgery
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7205
Homepage URL
Email	gbjimu@surg.med.tohoku.ac.jp

Sponsor
Institute	Japan Biliary Association
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Review Board, Tohoku University School of Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai
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	2017 Year 07 Month 07 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	2017 Year 07 Month 07 Day
Date of IRB	2017 Year 07 Month 24 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cohort case-control study

Management information
Registered date	2017 Year 06 Month 16 Day
Last modified on	2019 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031827