UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002148 |
|---|---|
| Receipt number | 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 13:15:08 |
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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
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
isihara-ry@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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