Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00398

2 Trial Registration Date

2014-03-14

i Registration Status

Prospective

3 Secondary IDs

2014/03/05

4 Source(s) of Funding

Hong Kong Cancer Fund

5 Primary Sponsor

Dr. Carmen Wong

6 Secondary Sponsor

Prof. Paul Chan

Function

Please specify

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

i Name

Ms. Alice Fung

ii Address

Room 426, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

+852 22528768

iv Email

alicefung@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Dr. Carmen Wong

ii Address

Room 408, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

+852 22528880

iv Email

carmenwong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Acceptability and Feasibility of HPV self sampling in poor attenders and non attenders of cervical cancer screening in Hong Kong

10 Public Title

HPV self sampling in poor/non cervical cancer screening attenders

i Public Title in Chinese 研究名稱

HPV DNA自行採集樣本測試研究

11 Short Title (Optional)

Acceptability and Feasibility of HPV self sampling in poor attenders and non attenders of cervical cancer screening in Hong Kong

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?

2013-12-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Cervical cancer

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

HPV self sampling procedure

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Once

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

usual care

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) Women who have never attended cervical cancer (PAP) screening, or 2) Women whose last cervical (PAP) screening was > 5 years ago

ii Exclusion Criteria

1) Women who do not understand Cantonese, mandarin or english
2) Women who has had an hysterectomy, removal of cervix, or past history of cervical cancer
3) women who have never had sexual intercourse
4) Women with reduced mobility and unable to conduct HPV self sampling independently

iii Age Minimum

25

iv Age Maximum

70

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

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-04-01

21 Target Sample Size

416

22 Recruitment Status

Unknown

23 Primary Outcome

1) To investigate the prevalence of HPV infection using HPV self sampling and on pap smear cytology in this at risk group

24 Secondary Outcome

2) to explore the acceptability and feasibility of HPV self sampling in this atrisk group

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-04-15

27 Primary Registry and Trial Identifying Number

ChiCTR-OCS-14004376

28 Date of Registration in Primary Registry

2014-03-14

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-04-15