Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00639

2 Trial Registration Date

2018-12-07

i Registration Status

Prospective

3 Secondary IDs

CREC Ref. No.: 2018.491

4 Source(s) of Funding

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

5 Primary Sponsor

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Janice Lin

ii Address

Rooms 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin

iii Phone

35052628

iv Email

janicelin@ent.cuhk.edu.hk

v Affiliation

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Michael Tong

ii Address

Rooms 84026 – 31, 6/F, Lui Che Woo Clinical Sciences Building (Professoriate Building), Prince of Wales Hospital, Shatin

iii Phone

35052628

iv Email

mtong@ent.cuhk.edu.hk

v Affiliation

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

A Cross-sectional Study on Nasopharyngeal Carcinoma Patients in Hong Kong with and without Allergic Rhinitis

10 Public Title

A Cross-sectional Study on Nasopharyngeal Carcinoma Patients in Hong Kong with and without Allergic Rhinitis

i Public Title in Chinese 研究名稱

香港鼻咽癌病人與鼻敏感的關係

11 Short Title (Optional)

A Cross-sectional Study on Nasopharyngeal Carcinoma Patients in Hong Kong with and without Allergic Rhinitis

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?

2018-11-09

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.491

14 Medical Condition Being Studied

Nasopharyngeal Carcinoma Patients with and without Allergic Rhinitis

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Questionnaire, skin prick test, peak nasal inspiratory flow and nasopharyngeal swabs will be obtained by authorized research assistants and medical students under supervision of investigators.

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Chinese nasopharyngeal carcinoma patients who completed course of radiotherapy

Positive in both Skin Prick Test and clinical diagnosis or negative in both Skin Prick Test and clinical diagnosis

Ability to understand the nature, scope and possible consequences of the study

Capability and willingness to comply with the requirements of the protocol

ii Exclusion Criteria

With rhinitis of non-allergic origin

Positive in Skin Prick Test only, but negative in clinical diagnosis, and vice versa

With prior nasal surgery

Distant metastasis

Recurrence of nasopharyngeal carcinoma

Respiratory tract infection within the past 30 days before taking nasal swab and peak nasal inspiratory flow readings

With co-exiting clinically major cardiovascular, respiratory, hepatic, neurological, endocrine, immunological or other major systemic diseases

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

0

Please specify

vi Study Objectives (Optional)

To observe for different factors relating to allergic rhinitis in Chinese nasopharyngeal carcinoma patients in Hong Kong; To investigate the correlation, if any, between allergic rhinitis and Chinese nasopharyngeal carcinoma

20 Anticipated trial start date

2018-12-14

21 Target Sample Size

324

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

To identify potential subjects with allergic rhinitis for further confirmation tests

ii The metric or method of measurement used

Questionnaire; Total Nasal Symptom Score and Skin Prick Test

iii The timepoint(s) of primary interest

December 2018-December 2020 (visit 1, visit 2...visit n)

24 Secondary Outcome

i The Name of the outcome

Nasal obstruction on allergic rhinitis; Microbiome analysis

ii The metric or method of measurement used

Peak Nasal Inspiratory Flow; Nasopharyngeal swab collection

iii The timepoint(s) of primary interest

December 2018-December 2020 (visit 1, visit 2...visit n)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-03-17

27 Primary Registry and Trial Identifying Number

ChiCTR1900021027

28 Date of Registration in Primary Registry

2018-12-07

Back History

Trial Detail