UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009531 |
|---|---|
| Receipt number | R000011187 |
| Scientific Title | Study on treatment after complete resection of high risk gastrointestinal stromal tumor (GIST) |
| Date of disclosure of the study information | 2012/12/13 |
| Last modified on | 2022/06/20 14:38:12 |
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Basic information
Public title
Study on treatment after complete resection of high risk gastrointestinal stromal tumor (GIST)
Acronym
STAR ReGISTry
Scientific Title
Study on treatment after complete resection of high risk gastrointestinal stromal tumor (GIST)
Scientific Title:Acronym
STAR ReGISTry
Region
| Japan |
Condition
Condition
Gastrointestinal stromal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to register patients who have undergone a curative resection (R0/R1 resection) in an initial gastrointestinal stromal tumor (GIST) and have been found to have high risk based on the modified-Fletcher Classification (Joensuu) and to study conditions and prognosis of their post surgical treatments. This study also covers an exploration of appropriate imatinib treatment period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence-free survival
Key secondary outcomes
-Overall survival
-Occurrence and severity of adverse events
-Completion of treatment
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) The diagnosis of GIST is confirmed by KIT-positive of resected specimen or acquiring of genetic mutations with c-kit and PDGFRA
2) The subject is classified as high risk based on the modified-Fletcher Classification (Joensuu)
3) In initial GIST, a complete gross resection had been conducted and the resection is within 3 years prior to registration (if recurrence is found at the time, the registration shall be permitted when above condition is met.)
4) Over 20 years old
5) Patients are able to provide written informed consent, if the patient died at the time of registration, a consent must be obtained from the legal representative of the person
(Unless it has been six months or more after the surgery)
6) After the surgery, a periodic imaging test (every 6 months) has been conducted to examine possibility of recurrence
Key exclusion criteria
1) In case the patient has other serious illnesses other than GIST (other cancer, cardiovascular disease, brain disease, and hepatorenal diseases etc).
2) Resection of metastases/ disseminated lesion was concluded in initial GIST, a complete gross resection
3) In case the physician determines that participation in the study is not appropriate.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshirou |
| Middle name | |
| Last name | Nishida |
Organization
National Cancer Center Hospital
Division name
Department of Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuoku, Tokyo 104-0045, Japan
TEL
03-3542-2511
tnishida@ncc.go.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nakagawa |
Organization
Translational Research Center for Medical Innovation
Division name
None
Zip code
650-0047
Address
1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe, Japan 650-0047
TEL
078-303-9093
Homepage URL
http://www.tri-kobe.org/
s-nakagawa@tri-kobe.org
Sponsor or person
Institute
The Research Group for Rare Neoplasms of Japan
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuoku, Tokyo 104-0045, Japan
Tel
03-3542-2511
tnishida@ncc.go.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
国立研究開発法人 国立がん研究センター 中央病院（東京都）
国立研究開発法人 国立がん研究センター 東病院（千葉県）
大阪警察病院（大阪府）
大阪大学医学部付属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 13 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
prospective non-interventional study
Management information
Registered date
| 2012 | Year | 12 | Month | 12 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011187
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/06/20 | 【STAR ReGISTry】プロトコル_1.4版（案）clean版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
