Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00615

2 Trial Registration Date

2018-07-18

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

Research Grant Council (Early Career Scheme)

5 Primary Sponsor

Research Grant Council

6 Secondary Sponsor

Not applicable

Function

Not Applicable

Please specify

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

i Name

Cheung Yin Ting

ii Address

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

39436833

iv Email

yinting.cheung@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

Yin Ting Cheung

ii Address

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

39436833

iv Email

yinting.cheung@cuhk.edu.hk

v Affiliation

School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

A Biobehavioral Model to Understanding Cognitive and Psychosocial Outcomes in Young Survivors of Childhood Leukemia

10 Public Title

Cognitive and Social Outcomes in Survivors of Childhood Leukemia

i Public Title in Chinese 研究名稱

兒童血癌生還者的認知和心理變化

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?

2018-02-01

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.701

14 Medical Condition Being Studied

Childhood leukemia

15 Intervention

i Types of intervention

Other

Please specify

No intervention involved. This is an observational study

ii Description/ name of Intervention/article

No intervention involved. This is an observational study

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

Diagnosed with acute lymphoblastic leukemia between the age of 0 and 18

Previously treated at a local institution in Hong Kong

≥ 3.0 years post cancer diagnosis

Participant and parent/guardian must understand Cantonese or Mandarin

ii Exclusion Criteria

Diagnosis of genetic disorder associated with cognitive impairment (e.g. Down Syndrome)

Pregnant or lactating

History of traumatic brain injury

History of neurological conditions known to limit cognitive function

Treated with cranial radiation

iii Age Minimum

10

iv Age Maximum

25

v Gender

Both Male and Female

18 Study Type

Observational

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

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-07-27

21 Target Sample Size

100 survivors of childhood cancer and 100 controls

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Cognitive and psychosocial outcomes

ii The metric or method of measurement used

Cognitive assessments and structured questionnaires

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

Sleep, physical activity, family functioning

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

2021-07-24

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-07-18