UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025210 |
|---|---|
| Receipt number | R000028996 |
| Scientific Title | Evaluation of endocervical glandular lesions using a scoring system and immunostain using p16&Ki67 antibodies. |
| Date of disclosure of the study information | 2016/12/12 |
| Last modified on | 2022/12/15 18:39:29 |
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Basic information
Public title
Evaluation of endocervical glandular lesions using a scoring system and immunostain using p16&Ki67 antibodies.
Acronym
Scoring system and immunostain
Scientific Title
Evaluation of endocervical glandular lesions using a scoring system and immunostain using p16&Ki67 antibodies.
Scientific Title:Acronym
Scoring system and immunostain
Region
| Japan |
Condition
Condition
noninvasitve endocervical glandular lesion
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine whether a scoring system is useful in cytological diagnosis of endocervical glandular lesions to detect adenocarcinoma in situ. Furthermore, we examined a utility of the immunostaining using p16&Ki67 antibodies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of scoring system
Key secondary outcomes
Expression of p16&Ki67 antibodies
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
Female
Key inclusion criteria
Cytodiagnosis was patient with atypical grandular cell (AGC) or adenocarcinoma in situ; or patient with grandular dysplasia or adenocarcinoma in situ by biopsy.
Key exclusion criteria
A minor or the patients who are hard to declare their intentions.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Tokunaga |
Organization
Tohoku university hospital
Division name
gynecology
Zip code
980-8574
Address
1-1,Seiryo-machi, Aoba-ku, Sendai-shi
TEL
022-717-7254
s-okamoto@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Okamoto |
Organization
Tohoku university hospital
Division name
gynecology
Zip code
980-8574
Address
1-1,Seiryo-machi, Aoba-ku, Sendai-shi
TEL
022-717-7254
Homepage URL
s-okamoto@med.tohoku.ac.jp
Sponsor or person
Institute
Department of gynecology, Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 12 | 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
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects were patients in whom a definitive diagnosis was made after a procedure that was more extensive than cervical conization.The cytological diagnosis the using scoring system was compared with the histopathological diagnosis.Furthermore, we investigated expression of p16&Ki67 in endocervical grandular dysplasia and adenocarcinoma in situ.
Management information
Registered date
| 2016 | Year | 12 | Month | 10 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028996
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
