Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00475

2 Trial Registration Date

2015-09-08

i Registration Status

Prospective

3 Secondary IDs

2015.237

4 Source(s) of Funding

Food and Health Bureau, The Hong Kong Special Administrative Region (HKSAR)

5 Primary Sponsor

Prof. Eliza Wong

6 Secondary Sponsor

Prof. Paul Chan

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ms. Nicole Huang

ii Address

Room 503, JC School of Public Health and Primary Care
Prince of Wales Hospital
Shatin
Hong Kong

iii Phone

2252-8408 / 2252-8406

iv Email

nicolehuang@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Eliza Wong

ii Address

Room 503, JC School of Public Health and Primary Care
Prince of Wales Hospital
Shatin
Hong Kong

iii Phone

22528772

iv Email

lywong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Molecular epidemiology of human papillomavirus (HPV) infection in Hong Kong women with cervical cytological abnormalities

10 Public Title

Molecular epidemiology of human papillomavirus (HPV) infection in Hong Kong women

i Public Title in Chinese 研究名稱

人類乳頭瘤病毒（HPV）感染的分子流行病學

11 Short Title (Optional)

Molecular epidemiology of human papillomavirus (HPV) infection

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-06-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.237

14 Medical Condition Being Studied

HPV infection & Cervical cancer

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

HPV DNA testing from the specimen of Pap smear test

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

Cross-sectional (Once)

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

No Comparative Treatments

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Women who: 1) are Hong Kong Chinese with Hong Kong Identity Card;

2) age ≥25 years old;

3) are able to speak Cantonese;

4) are able to understand the interview (as judge by the interviewer);

5) are able to give a written informed consent and

6) had sexual experience.

ii Exclusion Criteria

Immunocompromised women

iii Age Minimum

25

iv Age Maximum

65

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-09-11

21 Target Sample Size

600

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

1) To evaluate the prevalence of genital HPV genotypes (high-risk and low-risk) among cytological abnormalities and its association between genital HPV genotypes and various stages of cervical precancerous lesions.

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

Primary Outcome

i The Name of the outcome

2) To explore epidemiological risk factors associated to HPV genotypes, particularly in second peak of HPV prevalence in age group of 46-55 years.

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

1) To examine the uptake or willingness of taking HPV vaccination among women with cervical cytological abnormalities.

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

2) To assess utilization of health service related to cervical infection.

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2015-09-11