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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024431
Receipt No. R000028111
Scientific Title The role of endoscopyic resection for colitis-associated cancer treatment
Date of disclosure of the study information 2016/10/16
Last modified on 2019/04/21

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Basic information
Public title The role of endoscopyic resection for colitis-associated cancer treatment
Acronym The role of endoscopyic resection for colitis-associated cancer treatment
Scientific Title The role of endoscopyic resection for colitis-associated cancer treatment
Scientific Title:Acronym The role of endoscopyic resection for colitis-associated cancer treatment
Region
Japan

Condition
Condition colitis-associated cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the efficacy and safty of endoscopic resection for colitis-associated cancer and to explore whether total colectomy could be prevented.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess the development of dysplasia or cancer and the effect on survival after the intervention.
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' preference
Patients in remission
Key exclusion criteria Patinets with active colitis
No agreement of patinets
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Toshiharu
Middle name
Last name Sakurai
Organization Kindai university
Division name Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohnohigashi Osaka-Sayama
TEL 072-366-0221
Email sakurai@med.kindai.ac.jp

Public contact
Name of contact person
1st name Toshiharu
Middle name
Last name Sakurai
Organization Kindai university
Division name Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohnohigashi Osaka-Sayama
TEL 072-366-0221
Homepage URL
Email sakurai@med.kindai.ac.jp

Sponsor
Institute kindai university
Institute
Department

Funding Source
Organization kindai university
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 Kindai University
Address 377-2 Ohno-Higashi Osaka-sayama
Tel 072-366-0221
Email zizen@med.kindai.ac.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
2016 Year 10 Month 16 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
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To assess the development of dypslasia or cancer and the prognosis in patients who undergo endoscopic resection. To explore biomarkers to predict patients with colitis^associated cancer.

Management information
Registered date
2016 Year 10 Month 16 Day
Last modified on
2019 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028111

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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