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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003267
Receipt No. 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

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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
Email 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
Email kanaoka@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003955

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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