UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024431 |
|---|---|
| Receipt number | 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 | 2020/04/19 17:09:51 |
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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
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
sakurai@med.kindai.ac.jp
Sponsor or person
Institute
kindai university
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028111
