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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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