Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00301

2 Trial Registration Date

2011-12-08

iRegistration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

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

i Name

Winnie Samy

ii Address

Department of Anaesthesia & Intensive Care, CUHK

iii Phone

26323155

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, CUHK, PWH

vi Country

Hong Kong, SAR, China

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

i Name

Manoj Kumar Karmakar

ii Address

Department of Anaesthesia & Intensive Care, CUHK, PWH

iii Phone

26321311

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, CUHK, PWH

vi Country

Hong Kong, SAR, China

9 Official Scientific Title of the Study

Thoracic Paravertebral Block for Breast Cancer Surgery: Effects on Cancer Recurrence and Long Term Survival

10 Public Title

Thoracic Paravertebral Block for Breast Cancer Surgery: Effects on Cancer Recurrence and Long Term Survival

i Public Title in Chinese 研究名稱

not applicable, retrospective study, patient will be contacted by phone, consent waived

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong, SAR, China

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-08-16

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2011.286

14 Medical Condition Being Studied

Breast Cancer

15Intervention

i Types of intervention

Other

Please specify

Collect data from Clinical Management System, so informed consent has been exempted & approved by EC

ii Description/ name of Intervention/article

This study will involve reviewing patients’ clinical records and laboratory results from the Clinical Management System (patient database of Hospital Authority) for any cancer recurrence, metastasis or death for the coming 5 years who had participated in our previous ethics approved prospective, randomized, double-blinded study (CRE-2004.376.T) of patients having a standardized anaesthetic procedure during their breast cancer surgery.

iii Dosage form of the intervention

not pharmaceutical study

iv Dosage of the intervention

not pharmaceutical study

v Duration of the intervention

5 years follow-up

vi Frequency of the intervention

not pharmaceutical study

16Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

not pharmaceutical study

iii Dosage of the comparative treatments

not pharmaceutical study

iv Duration of the comparative treatments

not pharmaceutical study

v Frequency of the comparative treatments

not pharmaceutical study

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients who had participated in our previous ethics approved study “Continuous Thoracic Paravertebal Block: Effects on acute and chronic pain and Quality of life after breast cancer surgery” (CRE-2004.376.T)

ii Exclusion Criteria

Nil

iii Age Minimum

18 year old

iv Age Maximum

70 year old

v Gender

Female

18 Study Type

Observational

19Study 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

Single group

v Study Phase

Other

Please specify

not applicable

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-09-01

21 Target Sample Size

180

22 Recruitment Status

Complete

23 Primary Outcome

Review patients’ records for survival or mortality over 5 years after breast cancer surgery

24 Secondary Outcome

Review patients’ records for any incidence of metastatic spread or cancer recurrence over 5 years after breast cancer surgery

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2020-03-30

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-12001844

28 Date of Registration in Primary Registry

2012-01-05

Back History

Trial Detail