Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000576527
Ethics application status
Approved
Date submitted
23/03/2015
Date registered
3/06/2015
Date last updated
3/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
AustraLian Ovarian Cancer Assortment Trial to perform comprehensive genetic screens on women diagnosed with ovarian cancer.
Scientific title
AustraLian Ovarian Cancer Assortment Trial (ALLOCATE) to perform comprehensive genetic screens on women diagnosed with ovarian cancer for potential therapeutic targets and drug response modifiers, and to facilitate the biological assortment and selection of suitable patients for clinical trials of approved and investigational-targeted therapies.
Secondary ID [1] 286389 0
Nil
Universal Trial Number (UTN)
U1111-1168-5391
Trial acronym
ALLOCATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 294534 0
Condition category
Condition code
Cancer 294843 294843 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No intervention(s) will be made, but we will take tumour tissue sample from participants either by biopsy, or use archived formalin-fixed, paraffin-embedded tissue from previous surgery, in addition to a blood sample. A single sample of each blood and tumour will be taken at the time of consent. We will perform a comprehensive genetic screen with a next-generation sequencing panel to help us identify changes in the genes and proteins within the cancer. Initially, our work will focus on getting a better understanding of the specific types of changes in ovarian cancer. Over time we hope to use that information to design and implement better treatments for women with ovarian cancer.
Intervention code [1] 291457 0
Diagnosis / Prognosis
Intervention code [2] 292011 0
Early detection / Screening
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294606 0
Determination of the mutations involved in participants' tumours, compared with germline DNA extracted from blood using a customised next generation sequencing panel screening 30 genes associated with ovarian cancer for primary patient management
Timepoint [1] 294606 0
six to eight weeks after sample receipt
Secondary outcome [1] 313707 0
Clinical followup information and the genetic data from participants will be studied for patterns of mutations and drug responses by performing data linkage to patient medical records.
Timepoint [1] 313707 0
18 - 36 months after testing (retrospective)
Secondary outcome [2] 314929 0
Eventually, it is hoped the genetic data and followup data will facilitate the biological assortment and selection of suitable patients for clinical trials of approved and investigational-targeted therapies
Timepoint [2] 314929 0
36+ months after testing (retrospective)

Eligibility
Key inclusion criteria
Women presenting at Royal Women's Hospital or the Peter MacCallum Cancer Centre with recurrent epithelial ovarian cancer (including peritoneal and fallopian tube cancers), regardless of histological subtype
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion from collection of fresh biopsy tissue if not deemed safe. Archival FFPE (paraffinised tumour sample) from previous surgery will be used in this case.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - nonrandomised trial - all participants are screened with the ovarian cancer panel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - nonrandomised trial - all participants are screened with the ovarian cancer panel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Upon consenting, participants are assigned a study number. The laboratory technicians undertaking the genetic analysis and the pathologists approving the reports see only this study number and our internal laboratory number. The project manager re-identifies patients for the clinical report generation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is not a clinical trial involving the conventional test/placebo model, but a study making a novel genetic diagnostic panel available to participants, there are no statistical analyses performed, and there is no minimum number of participants to achieve study objectives.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/12/2013
Actual
10/12/2013
Date of last participant enrolment
Anticipated
1/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3598 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 3599 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 9386 0
3052 - Parkville
Recruitment postcode(s) [2] 9387 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 290962 0
Other Collaborative groups
Name [1] 290962 0
Victorian Comprehensive Cancer Centre
Country [1] 290962 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Department of Pathology,
Centre for Translational Pathology,
Parkville, VIC, 3010
Country
Australia
Secondary sponsor category [1] 290030 0
None
Name [1] 290030 0
Address [1] 290030 0
Country [1] 290030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292559 0
Human Research Ethics Committee, Peter MacCallum Cancer Centre
Ethics committee address [1] 292559 0
St Andrews Place, East Melbourne, VIC, 3002
Ethics committee country [1] 292559 0
Australia
Date submitted for ethics approval [1] 292559 0
17/06/2013
Approval date [1] 292559 0
07/10/2013
Ethics approval number [1] 292559 0
HREC/13/PMCC/11

Summary
Brief summary
This study aims to identify changes in the genes and proteins within the ovarian cancer tissues. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above presenting at Royal Women's Hospital or the Peter MacCallum Cancer Centre with recurrent epithelial ovarian cancer (including peritoneal and fallopian tube cancers), regardless of histological subtype. Study details: All participants in this study will be required to undergo a biopsy procedure on a single occasion to obtain a tumour tissue sample, or have archived formalin-fixed, paraffin-embedded tumour tissue retrieved from pathology laboratory archives. A blood sample will also be drawn. The samples will then be analysed using a next generation sequencing panel targeted to ovarian cancer. Initially, our work will focus on getting a better understanding of the specific types of changes in ovarian cancer. Over time we hope to use that information to design and implement better treatments for women with ovarian cancer. No treatments will be administered as part of this study. This study was designed to enable women with advanced ovarian cancer to be rapidly selected for clinical trials of targeted therapies.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 358 358 0 0
/AnzctrAttachments/368219-1330.PMCC Info Brochure ALLOCATE _v3_17June2013 CLEAN.pdf
Attachments [2] 359 359 0 0
/AnzctrAttachments/368219-1330.RWH Info Brochure ALLOCATE _v3_17June2013 CLEAN.pdf

Contacts
Principal investigator
Name 55934 0
A/Prof Linda Mileshkin
Address 55934 0
Peter MacCallum Cancer Centre,
St Andrews Place,
East Melbourne, VIC, 3002
Country 55934 0
Australia
Phone 55934 0
+61 03 96561111
Fax 55934 0
Email 55934 0
[email protected]
Contact person for public queries
Name 55935 0
Ms Tiffany Cowie
Address 55935 0
Department of Pathology,
The University of Melbourne,
VIC, 3010
Country 55935 0
Australia
Phone 55935 0
+61 03 90357914
Fax 55935 0
Email 55935 0
[email protected]
Contact person for scientific queries
Name 55936 0
Ms Tiffany Cowie
Address 55936 0
Department of Pathology,
The University of Melbourne,
VIC, 3010
Country 55936 0
Australia
Phone 55936 0
+61 03 90357914
Fax 55936 0
Email 55936 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.