Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00530

2 Trial Registration Date

2016-09-22

i Registration Status

Prospective

3 Secondary IDs

2016.196

4 Source(s) of Funding

THe Chinese University of Hong Kong Knowledge Transfer Project Fund

5 Primary Sponsor

THe Chinese University of Hong Kong Knowledge Transfer Project Fund

6 Secondary Sponsor

The Jockey Club School of Public Health and Primary Care

Function

Not Applicable

Please specify

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

i Name

Ms. Amy Wong

ii Address

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

iii Phone

2252 8408

iv Email

amy.wong@cuhk.edu.hk

v Affiliation

The Jockey Club School of Public Health and Primary Care, The CUHK

vi Country

Hong Kong

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

i Name

Eliza Wong

ii Address

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 Jockey Club School of Public Health and Primary Care , The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Knowledge transfer to increase access of cervical cancer screening among the difficult-to-reach group in Hong Kong: Community-based training on screening by self-sampling

10 Public Title

Cerival Cancer Screening among the difficult-to-reach group

i Public Title in Chinese 研究名稱

人類乳頭瘤病毒（HPV）自行採樣測試 (試點研究)

11 Short Title (Optional)

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?

2016-04-20

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.196

14 Medical Condition Being Studied

HPV infection

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

HPV DNA testing from self-sampling

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

One time only

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

Chinese women age between 40-65 years

Has not been screened for cervical cancer in the past 5 years

ii Exclusion Criteria

Pregnancy or women with a previous hysterectomy have any types of genital cancers, impaired immunity (e.g. Systemic Lupus Erythematosus, SLE) or on treatment for immunity (e.g. long term steroids users).

iii Age Minimum

40

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

2016-10-03

21 Target Sample Size

380

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

To develop an educational programme to increase the awareness of cervical cancer prevention and promote self-sampling as alternative cervical cancer screening to the community, particularly the under-screened female population.

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

NA

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

2017-10-06

27 Primary Registry and Trial Identifying Number

ChiCTR-SOC-16009272

28 Date of Registration in Primary Registry

2016-09-22

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Trial History Detail on 2016-10-04