UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020087 |
|---|---|
| Receipt number | R000023207 |
| Scientific Title | Study on predictive biomarkers for the progression to cervical cancer from the aspect of genomic and epigenomic analysis, and the application of personalized intervention |
| Date of disclosure of the study information | 2015/12/06 |
| Last modified on | 2023/06/12 10:38:52 |
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Basic information
Public title
Study on predictive biomarkers for the progression to cervical cancer from the aspect of genomic and epigenomic analysis, and the application of personalized intervention
Acronym
Development and application of Biomarkers for CIN
Scientific Title
Study on predictive biomarkers for the progression to cervical cancer from the aspect of genomic and epigenomic analysis, and the application of personalized intervention
Scientific Title:Acronym
Development and application of Biomarkers for CIN
Region
| Japan |
Condition
Condition
Cervical intraepithelial neoplasia(CIN)and cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To find predictive biomarkers for progression or regression of CINs
Basic objectives2
Others
Basic objectives -Others
To find predictive biomarkers for the regression or progression of CINs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Progression to CIN3 or cervical cancer or regression to normal
Key secondary outcomes
Regression to the normal cervix
Sustained CIN status
Immune responses
Genomic and epigenomic analysis
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who have the pathological diagnosis of CIN1 or CIN2
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Kawana |
Organization
The University of Tokyo Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(ext33407)
kkawana-tky@umin.org
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Kawana |
Organization
The University of Tokyo Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(ext33407)
Homepage URL
kkawana-tky@umin.org
Sponsor or person
Institute
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center
Division of Microbiology,Department of Pathology and Microbiology,Nihon University School of Medicine
Institute for Virus Research Kyoto University.
Department of Obstetrics and Gynecology,Chiba University
Akita University Graduate School of Medicine and Faculty of MedicineBioregulatory Medicine
Department of Obstetrics and Gynecology, keio University School of Medicine
National Institute of Infectious Diseases
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部付属病院（東京都）
国立がん研究センター研究所（東京都）
日本大学医学部微生物学分野（東京都）
京都大学 ウイルス研究所（京都府）
千葉大学大学院医学研究科 産婦人科学（千葉県）
秋田大学大学院医学系研究科器官病態学講座（秋田県）
慶應義塾大学 医学部 産婦人科学教室（東京都）
国立感染症研究所 （東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
http://go.umin.jp/index.html
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
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration period: Three years (December 2015 to December 2018)
Subjects: Patients who admit to Tokyo University Hospital, Keio University Hospital, Chiba University Hospital, or related medical centers and are histologically diagnosed as CIN1-2
Study type: Cohort Study
End point: Progression to CIN3
Analysis
1)Comprehensive genome and epigenome analysis
2)Immunological analysis
3)Analysis of vaginal and oral bacterial flora
Management information
Registered date
| 2015 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023207
