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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027785
Receipt No. R000031827
Scientific Title Prospective study on prognosis and diagnosis of gallbladder cancer.
Date of disclosure of the study information 2017/07/07
Last modified on 2019/03/24

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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
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
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

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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