UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027785 |
|---|---|
| Receipt number | 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 09:43:53 |
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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
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
gbjimu@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Japan Biliary Association
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031827
