UMIN-CTR Clinical Trial

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
Email	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
Email	yamashita.haruhiro.ud@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Okayama Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034498