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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007530
Receipt No. R000008893
Scientific Title Differential diagnosis of colorectal neoplastic and non-neoplastic lesions with real-time numerical color analysis using autofluorescence endoscopy
Date of disclosure of the study information 2012/03/19
Last modified on 2012/03/19

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Basic information
Public title Differential diagnosis of colorectal neoplastic and non-neoplastic lesions with real-time numerical color analysis using autofluorescence endoscopy
Acronym Differential diagnosis of colorectal lesions by autofluorescence endoscopy
Scientific Title Differential diagnosis of colorectal neoplastic and non-neoplastic lesions with real-time numerical color analysis using autofluorescence endoscopy
Scientific Title:Acronym Differential diagnosis of colorectal lesions by autofluorescence endoscopy
Region
Japan

Condition
Condition Colorectal tumor
Classification by specialty
Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The present prospective study was conducted to validate the cut-off value of AF index in the differential diagnosis between colorectal neoplastic and non-neoplastic lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic yields of the cut-off value for AF index in the differential diagnosis between colorectal neoplastic and non-neoplastic lesions
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 From November 2010 to August 2012
Following the detection of colorectal lesions in WL observation, the lesions were diagnosed for neoplastic or non-neoplastic.
Interventions/Control_2 In autofluorescence mode, color-tone sampling is performed on the area that had no halation or no bleeding points which might hamper analysis by the other endoscopist who did not know details of the lesion. Surrounding normal colonic mucosa was also analyzed for its color-tone in order to compare both G/R ratios. Lesions with G/R of < 1.01 are judged to be neoplastic and that with G/R of > 1.01 are considered to be non-neoplastic. Consecutively, all lesions analyzed in the present study are endoscopically removed or biopsied and the specimens are submitted to pathologic evaluation.
Finally, pre-removal diagnoses and final pathological diagnoses are compared to each other in order to calculate the diagnostic yield of G/R ratio in the differential diagnosis of colorectal neoplastic lesions from non-neoplastic lesions.

Pathologic diagnosis
Histopathologic examination of the endoscopically or surgically resected specimen was performed on hematoxylin and eosin-stained sections, with reference to Japanese classification of colorectal carcinoma4. Lesions were classified into 2 categories based on the final pathological diagnoses, neoplastic lesions and non-neoplastic lesions. Neoplastic lesions included 5 pathological types, submucosal invasive cancer, intramucosal cancer, tubular or villous adenoma, traditional serrated adenoma (TSA) and sessile serrated adenoma (SSA). Non-neoplastic lesion included only hyperplastic lesion.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Consecutive patients who were scheduled for screening colonoscopy or endoscopic removal of colorectal lesions in our department
Key exclusion criteria # Patients without written informed consent
# Patients who have bleeding tendency and can't undergo biopsy or endoscopic resection.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Aihara
Organization Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address 3-19-18, Nishi-shimbashi, Minato, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 19 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
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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

Management information
Registered date
2012 Year 03 Month 19 Day
Last modified on
2012 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008893

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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