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호주 교모 세포종 임상 업데이트 10,14일자

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조회 461 2021/10/14 22:28

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Registration number

ACTRN12619000640101
Ethics application status
Approved
Date submitted
12/04/2019
Date registered
30/04/2019
Date last updated
14/10/2021
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Study design

Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis
Statistical Analysis Plan (SAP) will be produced between finalisation of the CRF and database lock. This will include detailed descriptions of all statistical methodology to be utilised, planned analyses (with any ‘sensitivity’ analyses), together with master table and listing shells and outline figures for reporting. The SAP will be approved and signed prior to clean file.
Updated from
 
Reason: As per updated protocol
Updated on 14/10/2021 3:39:07 PM

Date of last data collection
Anticipated
Actual
Updated from
13/08/2021 
Reason: he trial is Recruiting: open for recruitment
Updated on 14/10/2021 3:39:07 PM
Updated from
20/05/2021 
Reason: Update
Updated on 5/11/2019 2:10:09 PM

Sample size
Target
40
Accrual to date
16
Final
Updated from
80 
Reason: As updated protocol one cohort with 40 patients
Updated on 14/10/2021 3:39:07 PM
Updated from
0 
Reason: So far 16 patients enrolled in the trial.
Updated on 14/10/2021 3:39:07 PM
Updated from
 
Reason: Just started with the recruitment
Updated on 5/11/2019 2:10:09 PM
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Updated from
NSW<br />  
Reason: Additional sites have included for patients able to access new novel treatment for GBM in another states of Australia.
Updated on 14/10/2021 3:39:07 PM
Recruitment hospital [1] 20729 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 20730 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment hospital [3] 20731 0
The Canberra Hospital - Garran
Recruitment hospital [4] 20732 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 35537 0
4120 - Greenslopes
Inserted
 
Reason: New site
Updated on 14/10/2021 3:39:07 PM
Recruitment postcode(s) [2] 35538 0
2605 - Garran
Inserted
 
Reason: New site
Updated on 14/10/2021 3:39:07 PM
Recruitment postcode(s) [3] 35539 0
3168 - Clayton
Inserted
 
Reason: New site
Updated on 14/10/2021 3:39:07 PM
Deleted Postcode
2031 - Randwick  
Reason: 3 more hospitals are participating with PAX1 treatment for patients with recurrent Glioblastoma.
Updated on 14/10/2021 3:39:07 PM
Recruitment outside Australia
Country [1] 24207 0
Korea, Republic Of
Inserted
 
Reason: 5 Additional sites in South Korea.
Updated on 14/10/2021 3:39:07 PM
State/province [1] 24207 0
Inserted
 
Reason: 5 Additional sites in South Korea.
Updated on 14/10/2021 3:39:07 PM


Contacts
Principal investigator
Updated from
Prof  
Reason: The change of PI for the study is approved by HREC on 25/02/2021
Updated on 14/10/2021 3:39:07 PM
Name 92634 0
Dr Ashanya Malalasekera
Updated from
Charlie Teo  
Reason: New Principal investigator.
Updated on 14/10/2021 3:39:07 PM
Address 92634 0
The address for Scientia Clinical Research is;

5 Bright Building Corner High, Avoca st Randwick NSW 2031.
Updated from
Prince of Wales Private Hospital, Barker Street, Randwick, NSW, 2031  
Reason: Lead site Scientia Clinical Research
Updated on 14/10/2021 3:39:07 PM
Country 92634 0
Australia
Phone 92634 0
+61 02 9382 5820
Updated from
+61 (0)296504940  
Reason: New study principal investigator
Updated on 14/10/2021 3:39:07 PM
Fax 92634 0
Email 92634 0
Ashanya.malalasekera@health.nsw.gov.au
Updated from
laine@neuroendoscopy.info  
Reason: New PI
Updated on 14/10/2021 3:39:07 PM
Contact person for public queries
Updated from
Mr  
Reason: Change of contact person due to Mr Samuel Lee does not longer works for The company
Updated on 14/10/2021 3:39:07 PM

            Intervention code [1] 314185 0
Treatment: Drugs
Comparator / control treatment
There is not control treatment for the study
Updated from
No control group. Each arm will be compared against historical data generated at the lead clinical trial site over the past 5 years.  
Reason:
The changes to the protocol were made after 6 patients were enrolled in cohort B.
Updated on 14/10/2021 3:39:07 PM

개입 코드 [1]

치료: 약물




대조군/제어 처리

연구에 대한 제어 치료가 없습니다.






업데이트 위치
제어 그룹이 없습니다. 각 부문을 지난 5년간 주요 임상시험 현장에서 생성된 과거 데이터와 비교한다.





이유:
프로토콜에 대한 변경은 6명의 환자가 코호트 B에 등록한 후에 이루어졌다.
14/10/2021 오후 3:39:07에 업데이트됨

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