UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012406 |
|---|---|
| Receipt number | R000014517 |
| Scientific Title | Human papillomavirus detection, genotyping and integration in uterine cervical neoplasia patients. |
| Date of disclosure of the study information | 2013/11/26 |
| Last modified on | 2013/11/26 16:50:59 |
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Basic information
Public title
Human papillomavirus detection, genotyping and integration in uterine cervical neoplasia patients.
Acronym
HPV integration in cervical neoplasia.
Scientific Title
Human papillomavirus detection, genotyping and integration in uterine cervical neoplasia patients.
Scientific Title:Acronym
HPV integration in cervical neoplasia.
Region
| Japan |
Condition
Condition
uterine cervical intraepithelial neoplasia, and cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the HPV integration rate, genotyping, and quantification of virus number in uterine cervical neoplasia during medical treatments.
Basic objectives2
Others
Basic objectives -Others
This is the epidemiological study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The evaluation of integration rate of HPV in uterine cervical neoplasia.
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
punch biopsy from uterine cervix
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The women who has diagnosed with cervical intraepithelial neoplasia or cervical cancer.
Key exclusion criteria
not available
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Ohmichi |
Organization
Osaka Medical College
Division name
Obstetrics and gynecology
Zip code
Address
Daigaku-machi 2-7, Takatsuki, Osaka
TEL
072-683-1221
m-ohmichi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshito Terai |
Organization
Osaka Medical College
Division name
Obstetrics and Gynecology
Zip code
Address
Daigaku-machi 2-7, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
y-terai@poh.osaka-med.ac.jp
Sponsor or person
Institute
Dpt. of Obstetrics and Gynecology
Osaka Medical College
Institute
Department
Personal name
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
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
| 2013 | Year | 11 | Month | 26 | 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
| 2011 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 26 | Day |
Last modified on
| 2013 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014517
