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Trial registered on ANZCTR


Registration number
ACTRN12615000476538
Ethics application status
Approved
Date submitted
5/05/2015
Date registered
14/05/2015
Date last updated
29/07/2019
Date data sharing statement initially provided
29/07/2019
Date results information initially provided
29/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Collection and banking of fresh tumours for frozen storage for patients undergoing planned excision of tumours
Scientific title
Patients with solid tumours that are accessible can bank their tumours in a dedicated tumour bank for long term fresh frozen storage conditions for the possible future production of an autologous cancer vaccine, the latter being a separate study.
Secondary ID [1] 286637 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid tumours 294960 0
Condition category
Condition code
Cancer 295222 295222 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There is no intervention. A sample of tumour will be taken from routine, planned tumour removal surgery. The sample will go into long term frozen storage. The tumour sample may be used in the future to manufacture an autologous cancer treatment vaccine. The tumour will be stored for an initial period of up to 3 years.
Intervention code [1] 291779 0
Not applicable
Comparator / control treatment
There is no intervention and no comparator or control in this study. It is a tissue donation / banking project.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294978 0
To obtain fresh tumour tissue during planned surgery in a safe & ethical manner for long term frozen storage. Participants will have signed informed consent prior to their routine surgery; a patient registration form will be completed prior to surgery to arrange logistics support; a tumour requisition form will be completed to document the sample traceability, tumour banking process and final location of the tumour in the repository. Participants are identified by a tumour bank ID / barcode to ensure confidentiality and privacy compliance.
Timepoint [1] 294978 0
Day of surgery / Day 1
Secondary outcome [1] 314498 0
None
Timepoint [1] 314498 0
N/A

Eligibility
Key inclusion criteria
- Adults 18 years of age and over
- Planned surgery as routine treatment for cancer from which tumour can be sourced
- In the investigator's opinion, has a tumour of a size that is likely to yield at least 1 cm3
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment for cancer in the 4 weeks prior to tumour excision surgery
- Current or past history of active autoimmune disease
- Known HIV infection
- Chronic hepatitis
- History of organ transplant or other condition requiring immunosuppressant medications
- Chronic systemic corticosteroid therapy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
None, tumour will be banked only.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6375 0
Northern Cancer Institute - St Leonards
Recruitment hospital [2] 6376 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 13926 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 291211 0
Commercial sector/Industry
Name [1] 291211 0
Regeneus Ltd
Address [1] 291211 0
25 Bridge Street
Pymble 2073 NSW
Country [1] 291211 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Regeneus Ltd
Address
25 Bridge Street
Pymble 2073 NSW
Country
Australia
Secondary sponsor category [1] 289890 0
None
Name [1] 289890 0
Address [1] 289890 0
Country [1] 289890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293785 0
Bellberry HREC
Ethics committee address [1] 293785 0
129 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 293785 0
Australia
Date submitted for ethics approval [1] 293785 0
11/02/2015
Approval date [1] 293785 0
07/04/2015
Ethics approval number [1] 293785 0
2015-02-078
Ethics committee name [2] 295629 0
Research Office, Northern Sydney Local Health District
Ethics committee address [2] 295629 0
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards, NSW, 2065
Ethics committee country [2] 295629 0
Australia
Date submitted for ethics approval [2] 295629 0
10/08/2015
Approval date [2] 295629 0
05/04/2016
Ethics approval number [2] 295629 0
RESP/15/197

Summary
Brief summary
The objective of this project is to collect tumour tissue from patients undergoing elective surgery for the removal of primary tumour or metastases.

Who is it for?
You may be eligible to participate in this project if you are aged 18 years or above and are planning to undergo surgery as routine treatment for cancer from which tumour can be sourced.

Study details:
Participants in this project will undergo routine tumour removal surgery as planned. A tumour sample is obtained from this surgery and put into long term frozen storage for up to 3 years. The tissue may be used for potential manufacture into an autologous therapeutic cancer vaccine for use within the same patient, at a time in the future should that patient’s medical oncologist recommend this treatment. This future treatment is a separate project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56974 0
A/Prof Nick Pavlakis
Address 56974 0
Northern Cancer Institute
Level 1, 38 Pacific Highway
St Leonards NSW 2065
Country 56974 0
Australia
Phone 56974 0
+61 2 9437 1900
Fax 56974 0
Email 56974 0
info@northerncancerinstitute.com.au
Contact person for public queries
Name 56975 0
Ms Iona Nicolson-Bowles
Address 56975 0
Northern Cancer Institute
Level 1, 38 Pacific Highway
St Leonards NSW 2065
Country 56975 0
Australia
Phone 56975 0
+61 2 9437 1900
Fax 56975 0
Email 56975 0
info@northerncancerinstitute.com.au
Contact person for scientific queries
Name 56976 0
Ms Janet Wilson
Address 56976 0
Regeneus Ltd
25 Bridge St
Pymble 2073 NSW
Country 56976 0
Australia
Phone 56976 0
+61 2 9499 8010
Fax 56976 0
Email 56976 0
janet.wilson@regeneus.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary