UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001156 |
|---|---|
| Receipt number | R000001253 |
| Scientific Title | HLA gene polymorphisms and development of cervical cancer in a Japanese population; a case-control study |
| Date of disclosure of the study information | 2008/05/16 |
| Last modified on | 2008/05/15 13:37:50 |
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Basic information
Public title
HLA gene polymorphisms and development of cervical cancer in a Japanese population; a case-control study
Acronym
Cervical cancer and HLA gene polymorphism; a case-control study
Scientific Title
HLA gene polymorphisms and development of cervical cancer in a Japanese population; a case-control study
Scientific Title:Acronym
Cervical cancer and HLA gene polymorphism; a case-control study
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine high-risk HLA alleles and low-risk HLA alleles for development of cervical cancer
Basic objectives2
Others
Basic objectives -Others
To assess the association between histological findings of cervical cancer and HPV type
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
HLA alleles found more frequently or less frequently in cervical cancer patients compared with in healthy women.
Key secondary outcomes
Histological characteristics of HPV18-positive squamous cell carcinima of the cervix
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Cases;
1. Patients with stage Ib to IVb cervical cancer diagnosed within 8 weeks before enrollment.
2. Previously untreated patiensta.
3. Written informed consent
Controls;
1. Women with normal cytology examined within 8 weeks before enrollment.
2. No past history of HPV infection, CIN and cervical cancer
3. Written informed consent
Key exclusion criteria
Cases
1. Women with other gynecologic malignancies or the past history of these diseases.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yoshikawa |
Organization
University of Tsukuba
Division name
Department of Obstetrics and Gynecology, Graduate School of Comprehensive Human Sciences
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
029-853-3049
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Oki |
Organization
University of Tsukuba
Division name
Department of Obstetrics and Gynecology, Graduate School of Comprehensive Human Sciences
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
029-853-3062
Homepage URL
a-oki@md.tsukuba.ac.jp
Sponsor or person
Institute
'HLA gene polymorphisms and development of cervical cancer in a Japanese population; a case-control study' group
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 05 | Month | 16 | 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
Date of protocol fixation
| 2007 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
To compare the types of Human papillomavirus(HPV) and the frequencies of HLA types between the patients of the cervical cancer and their age-matched controls.
Management information
Registered date
| 2008 | Year | 05 | Month | 15 | Day |
Last modified on
| 2008 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001253
