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

Email



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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name