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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030361
Receipt No. 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 2017/12/12

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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
Middle name
Last name Haruhiro Yamashita
Organization National Hospital Organization Okayama Medical Center
Division name Gastroenterology
Zip code
Address 1711-1 Tamasu, Kita-ku, Okayama-shi, Okayama
TEL 086-294-9911
Email haruymst@okayamamc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiro Yamashita
Organization National Hospital Organization Okayama Medical Center
Division name Gastroenterology
Zip code
Address 1711-1 Tamasu, Kita-ku, Okayama-shi, Okayama
TEL 086-294-9911
Homepage URL
Email haruymst@okayamamc.jp

Sponsor
Institute National Hospital Organization Okayama Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 25 Day
Last follow-up date
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
2017 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034498

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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