UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011826
Receipt number R000013823
Scientific Title Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.
Date of disclosure of the study information 2013/09/20
Last modified on 2015/03/21 18:48:48

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Basic information

Public title

Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.

Acronym

Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.

Scientific Title

Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.

Scientific Title:Acronym

Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the validity of annual endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of metachronous gastric cancer which does not meet the criteria of ESD between patients with and without annual surveillance endoscopy.

Key secondary outcomes

The Clinicopathological features of metachronous gastric cancers.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent endoscopic submucosal dissection for gastric cancer.
Pathologically diagnosed as curative resection.

Key exclusion criteria

Pathologically diagnosed as non-curative resection.

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisashi Doyama

Organization

Ishikawa Prefectural Central Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-1, Kuratsukihigashi, Kanazawa city, Ishikawa 920-8530, Japan

TEL

076-237-8211

Email

doyama.134@ipch.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyoshi Nakanishi

Organization

Ishikawa Prefectural Central Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-1, Kuratsukihigashi, Kanazawa city, Ishikawa 920-8530, Japan

TEL

076-237-8211

Homepage URL


Email

nakanishi@ipch.jp


Sponsor or person

Institute

Ishikawa Prefectural Central Hospital

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


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

石川県立中央病院(石川県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2013 Year 09 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 14 Day

Last follow-up date

2014 Year 03 Month 14 Day

Date of closure to data entry

2014 Year 03 Month 14 Day

Date trial data considered complete

2014 Year 03 Month 14 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information

retrospective cohort study


Management information

Registered date

2013 Year 09 Month 20 Day

Last modified on

2015 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013823


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name