UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039391
Receipt number R000044778
Scientific Title Retrospective study for clinicopathological characteristics of superficial non-ampullary duodenal epithelial tumor
Date of disclosure of the study information 2020/05/01
Last modified on 2020/02/04 23:27:36

* 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

Retrospective study for clinicopathological characteristics of superficial non-ampullary duodenal epithelial tumor

Acronym

Clinicopathological characteristics of SNADET

Scientific Title

Retrospective study for clinicopathological characteristics of superficial non-ampullary duodenal epithelial tumor

Scientific Title:Acronym

Clinicopathological characteristics of SNADET

Region

Japan


Condition

Condition

Adenoma and early carcinoma

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify clinical predictors of SNADET with malignant potential

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Clinical findings correlated with the histological grade of category 4/5 in final histopathology

Key secondary outcomes



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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with duodenal adenoma and carcinoma that undergone endoscopic or surgical resection

Key exclusion criteria

1)Lesions with gastric or extensive pancreatic involvement
2)Recurrent or residual lesion after endoscopic resection
3)Carcinomas invading the muscularis propria (T2) and deeper (T3 and T4)
4)Familial adenomatous polyposis

Target sample size

320


Research contact person

Name of lead principal investigator

1st name Noriya
Middle name
Last name Uedo

Organization

Osaka International Cancer Institute

Division name

Gastrointestinal Oncology

Zip code

541-8567

Address

3-1-69 Otemae, Chuo-ku, Osaka

TEL

06-6945-1181

Email

uedou-no@mc.pref.osaka.jp


Public contact

Name of contact person

1st name Katsunori
Middle name
Last name Matsueda

Organization

Osaka International Cancer Institute

Division name

Gastrointestinal Oncology

Zip code

541-8567

Address

3-1-69 Otemae, Chuo-ku, Osaka

TEL

06-6945-1181

Homepage URL


Email

rge43gs@yahoo.co.jp


Sponsor or person

Institute

Osaka International Cancer Institute

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka International Cancer Institute institutional review board

Address

3-1-69 Otemae, Chuo-ku, Osaka

Tel

06-6945-1181

Email

rinri01@opho.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



Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 01 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

328

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

2020 Year 02 Month 01 Day

Date of IRB

2020 Year 01 Month 28 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2020 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrieving information from medical records or stored endoscopic images and we investigate the major outcomes in this retrospective study.


Management information

Registered date

2020 Year 02 Month 04 Day

Last modified on

2020 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name