UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024901 |
|---|---|
| Receipt number | R000028317 |
| Scientific Title | Multicenter prospective cohort study of prognosis for T1 colorectal carcinoma |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2022/02/07 13:22:01 |
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Basic information
Public title
Multicenter prospective cohort study of prognosis for T1 colorectal carcinoma
Acronym
Cohort study of prognosis for T1 CRC
Scientific Title
Multicenter prospective cohort study of prognosis for T1 colorectal carcinoma
Scientific Title:Acronym
Cohort study of prognosis for T1 CRC
Region
| Japan |
Condition
Condition
Colorectal carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term outcomes more than 10 years among patients with T1 colorectal carcinoma in relation to the treatment methods, and the clinical validity of the Japanese Society for Cancer of the Colon and Rectum guidelines.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate
Key secondary outcomes
Disease free survival rate (5 years, 10 years)
Overall survival period(5 years, 10 years)
Outcomes after recurrence
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with T1 colorectal carcinoma who underwent endoscopic resection or surgical resection
Key exclusion criteria
1)Colotic cancer
2)Familiar adenomatous polyposis
3)Synchronous colorectal invasive carcinoma (including previous history)
4)Active carcinoma of other organs
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
cancer@gol.com
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Oka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
734-8551
Address
1-2-3, kasumi, Minami-ku, Hiroshima
TEL
082-257-5939
Homepage URL
oka4683@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development, Ministry of Health, Labour and Welfare
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
Kyoto Prefectural University of Medicine
Address
Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
Tel
075-251-5111
m-muramatsu76@pref.kyoto.lg.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
| 2017 | Year | 01 | 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
1527
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2016 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028317
