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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033989
Receipt No. R000038755
Scientific Title Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Date of disclosure of the study information 2018/09/01
Last modified on 2018/09/01

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Basic information
Public title Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Acronym Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Scientific Title Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Scientific Title:Acronym Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Region
Japan

Condition
Condition colorectal epithelial neoplasm
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the non-extension sign in assessing the optical diagnosis of colorectal epitherial neoplasm.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of each modality in diagnosing SM-deep cancer in adenoma and early colorectal caner with non-extension sign as an index for the diagnosis of SM-deep cancer.
Key secondary outcomes 1.Comparing the accuracy of conventional endoscopy using non-extension sign, magnifying narrow-band imaging, and magnifying chromoendoscopy for optical diagnosis.
2.Others, evaluate all the various result.

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 1. Patients performed endoscopic or surgical resection for colorectal epithelial neoplasm (adenoma and early colorectal cancer)
2. ECOG-performance status is 0 or 1 point.
3. Over 20 years old
4. Written informed consent
Key exclusion criteria 1. Pedunculated-type lesion
2. Serrated lesion
3. Lesions that are difficult to assess because observation conditions are poor.
4. Impossible pathological evaluation
5. Cases are inflammatory bowel disease, colitis-associated colorectal cancer, advanced cancer, after colon resection, familial adenomatous polyposis.
6. Patients with serious complication.
7. Patients who were judged inappropriate by their physicians.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Hisabe
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1, Zokumyoin Chikushino-city, Fukuoka, Japan
TEL 092-921-1011
Email hisabe@cis.fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuhisa Yasaka
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1, Zokumyoin Chikushino-city, Fukuoka, Japan
TEL 092-921-1011
Homepage URL
Email tatsuhisa1023@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology, Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization Fukuoka University Chikushi Hospital
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
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 福岡大学筑紫病院

Other administrative information
Date of disclosure of the study information
2018 Year 09 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
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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information non-extension sign;
Indigo carmine is sprayed and the colonic wall is strongly extended by endoscopic insufflation of a large volume of air. The area of intramucosal cancer become flattened and extended. On the other hand, the area of SM-deep cancer can be seen as an elevation of the surrounding mucusa due to localized thickening and hardening.
We observe the lesion from the lesion from the front and oblique or tangential directions. Lesions are assessed as positive for non-extension sign if any of the following 3 findings are seen.
1. Rigidity against a background circular arc
2. Trapezoid elevation
3. Converging mucosal folds

Management information
Registered date
2018 Year 09 Month 01 Day
Last modified on
2018 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038755

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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