UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030361 |
|---|---|
| Receipt number | R000034498 |
| Scientific Title | A multicenter, prospective observational study of treatment and prognosis in patients with primary small bowel cancer |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2021/12/15 09:42:58 |
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Basic information
Public title
A multicenter, prospective observational study of treatment and prognosis in patients with primary small bowel cancer
Acronym
NHOD-SBC
Scientific Title
A multicenter, prospective observational study of treatment and prognosis in patients with primary small bowel cancer
Scientific Title:Acronym
NHOD-SBC
Region
| Japan |
Condition
Condition
Small bowel cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the optimal therapy in national registry patients with primary small bowel, registered by utilizing National Hospital Organization Network, through analysis of the treatment contents and prognoses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival.
Incidence of adverse events.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)With primary small bowel cancer excluding newly-diagnosed duodenal papillary carcinoma
(2)Confirmed pathologically as adenocarcinoma
(3)Provided written consent by their free will
Key exclusion criteria
(1)Whose treatment contents cannot be grasped
(2)Where it has active double cancer and cannot determine the cause that affects prognosis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Haruhiro |
| Middle name | |
| Last name | Yamashita |
Organization
National Hospital Organization Okayama Medical Center
Division name
Internal Medicine
Zip code
701-1192
Address
1711-1
TEL
0862949911
yamashita.haruhiro.ud@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Haruhiro |
| Middle name | |
| Last name | Yamashita |
Organization
NHO Okayama Medical Center
Division name
Internal Medicine
Zip code
701-1192
Address
1711-1
TEL
0862949911
Homepage URL
yamashita.haruhiro.ud@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Okayama Medical Center
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
National Hospital Organization Okayama Medical Center
Address
Kitaku Tamasu 1711-1 Okayama City
Tel
0862949911
yamashita.haruhiro.ud@mail.hosp.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
岡山医療センター（岡山県）、大阪医療センター（大阪府）、北海道がんセンター（北海道）、北海道医療センター（北海道）、渋川医療センター（群馬県）、水戸医療センター（茨城県）、相模原病院（神奈川県）、まつもと医療センター（長野県）、米子医療センター（鳥取県）、敦賀医療センター（福井県）、福山医療センター（広島県）、東広島医療センター（広島県）、岩国医療センター（山口県）、関門医療センター（山口県）、四国がんセンター（愛媛県）、小倉医療センター（福岡県）、九州がんセンター（福岡県）、別府医療センター（大分県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 25 | 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
54
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
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2017 | Year | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034498
