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호주 교모 세포종 임상 업데이트 10,14일자
  • 21/10/14 22:28
  • 조회 501
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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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