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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002148
Receipt No. R000002621
Scientific Title Prospective evaluation of autofluoroscence imaging endoscopy for screening of squamous mucosal high-grade neoplasia in the esophagus
Date of disclosure of the study information 2009/07/01
Last modified on 2010/12/06

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Basic information
Public title Prospective evaluation of autofluoroscence imaging endoscopy for screening of squamous mucosal high-grade neoplasia in the esophagus
Acronym Prospective evaluation of autofluoroscence imaging endoscopy for screening of esophageal neoplasia
Scientific Title Prospective evaluation of autofluoroscence imaging endoscopy for screening of squamous mucosal high-grade neoplasia in the esophagus
Scientific Title:Acronym Prospective evaluation of autofluoroscence imaging endoscopy for screening of esophageal neoplasia
Region
Japan

Condition
Condition Esophageal neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the diagnostic yield of autofluoroscence imaging (AFI) endoscopy for screening of squamous mucosal high-grade neoplasia of the esophagus in experienced and less experienced endoscopists.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The primary outcome variable in this study was the sensitivity of AFI on a per lesion basis.
Key secondary outcomes (1) The positive predictive value (PPV) of NBI in a per lesion basis; (2) the sensitivity, specificity, PPV, negative predictive value (NPV) and accuracy of AFI in a per patient basis. (3) The differences in sensitivities, specificities, NPVs, PPVs and accuracy with regard to study periods, endoscopists, lesions' size and HGIN or invasive cancer.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopic screening using AFI was performed.
Interventions/Control_2 Endoscopic screening using AFI was performed by experienced and less-experienced endoscopists.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) patients with present esophageal neoplasias, (2) patients with past history of esophageal neoplasias treated with endoscopic resection, (3) patients with present or past history of head and neck cancer.
Key exclusion criteria Patients were excluded if they had previously undergone an operation, chemotherapy or radiotherapy for esophageal cancer, or had undergone chromoendoscopy with iodine staining within 6 months or allergic to iodine solution.
Target sample size 380

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryu Ishihara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ryu Ishihara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511
TEL 06-6972-1181
Homepage URL
Email isihara-ry@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor N/A
Name of secondary funder(s) N/A

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
2009 Year 07 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 Completed
Date of protocol fixation
2009 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information Initial routine inspection was performed using AFI. Screening with AFI was followed by chromoendoscopy with iodine solution. For all lesions, their location (distance and quadrant) and size were recorded by comparison with the known diameter of open forceps. The lesions detected in each method were matched based on the distance and quadrant of the lesions. Biopsy specimens were taken from iodine-unstained lesions.

Management information
Registered date
2009 Year 06 Month 30 Day
Last modified on
2010 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002621

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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