UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003267 |
|---|---|
| Receipt number | R000003955 |
| Scientific Title | Prospective study of fecal RNA testing for detecting colorectal cancer in subjects undergoing colonoscopy |
| Date of disclosure of the study information | 2010/02/28 |
| Last modified on | 2013/08/29 15:36:09 |
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Basic information
Public title
Prospective study of fecal RNA testing for detecting colorectal cancer in subjects undergoing colonoscopy
Acronym
Prospective study of fecal RNA testing for detecting colorectal cancer in subjects undergoing colonoscopy
Scientific Title
Prospective study of fecal RNA testing for detecting colorectal cancer in subjects undergoing colonoscopy
Scientific Title:Acronym
Prospective study of fecal RNA testing for detecting colorectal cancer in subjects undergoing colonoscopy
Region
| Japan |
Condition
Condition
Colorectal cancer and advanced adenoma (at least 1 cm in diameter )
Classification by specialty
| Gastroenterology | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify effectiveness of fecal RNA testing for colorectal cancer screening in comparison with fecal occult blood test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity and specificity of colorectal cancer and advanced adenoma
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 40 years to 79 years when registered
2. Signed the informed consent to participate in the study
Key exclusion criteria
1. History of colorectal cancer or under treatment for colorectal cancer
2. Familial adenomatous polyposis, family history of hereditary non-polyposis colorectal cancer and inflammatory bowel disease (ulcerative colitis and crhon's disease)
3. under treatment for malignant disease other than colorectal cancer
4. Diagnosis of iron deficient anemia within 6 months
5. Brightly visible rectal bleeding within 1 months
6. Pregnancy
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kanaoka |
Organization
Hamamatsu University School of Medicine
Division name
Department of Molecular Diagnosis
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2330
kanaoka@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Kanaoka |
Organization
Hamamatsu University School of Medicine
Division name
Department of Molecular Diagnosis
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2330
Homepage URL
kanaoka@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Corporate R&D Center, OLYPUS CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
松島クリニック Matsushima Clinic
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Double blind, prospective, cohort study
Management information
Registered date
| 2010 | Year | 02 | Month | 28 | Day |
Last modified on
| 2013 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003955
