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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621001285842
Ethics application status
Approved
Date submitted
7/07/2021
Date registered
23/09/2021
Date last updated
15/12/2024
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Whole genome sequencing in high risk breast cancer patients
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Scientific title
Whole genome sequencing in high risk breast cancer patients
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Secondary ID [1]
304721
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
breast cancer
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Condition category
Condition code
Cancer
320332
320332
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The specified interventions for this trial are:
1. 3 core biopsy samples to be taken at the time of surgical clip insertion by a qualified radiologist. The surgical clip is inserted just prior (typically within a week) to the commencement of neo-adjuvant chemotherapy.
2. Pre treatment blood samples will be taken (3 x 10 ml)
3. Post treatment blood samples will be taken at the completion of chemotherapy (approximately 3-4 months) (2 x10 ml).
4. Surgery at the completion of the treatment will be the standard procedure advised by your surgeon.
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Intervention code [1]
321102
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The breast tissue core biopsy will be subjected to whole genome sequencing and a Variant report prepared
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Assessment method [1]
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Timepoint [1]
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Core biopsy collection 1 week prior to initiation of neoadjuvant chemotherapy
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Primary outcome [2]
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normal DNA (from blood) will be subjected to whole genome sequencing and a Variant report prepared
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Assessment method [2]
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Timepoint [2]
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Blood collection prior to initiation of neoadjuvant chemotherapy
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Primary outcome [3]
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Circulating Tumour Cells will be purified from pre- and post- treatment blood samples and analysed.
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Assessment method [3]
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Timepoint [3]
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Post-chemotherapy blood sample will be taken a week after therapy completion; analysis of circulating tumour cells will then be made
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Secondary outcome [1]
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Following resection and standard diagnostic pathology assessment, any residual excess to diagnosis will be process for DNA extraction and sequenced.
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Assessment method [1]
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Timepoint [1]
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At the completion of neo-adjuvant chemotherapy course, patient will undergo surgery (as standard of care); residual tumour excess to diagnostic requirement will be sequenced.
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Eligibility
Key inclusion criteria
Patients must be diagnosed with a breast cancer that will be treated via a neo-adjuvant pathway.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/01/2022
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Actual
27/07/2022
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
70
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Accrual to date
24
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
19932
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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The Wesley Hospital - Auchenflower
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Recruitment hospital [5]
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St Vincent's Private Hospital Northside - Chermside
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Recruitment postcode(s) [1]
34634
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
34635
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
34636
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3000 - Melbourne
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Recruitment postcode(s) [4]
43532
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4066 - Auchenflower
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Recruitment postcode(s) [5]
43533
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4032 - Chermside
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Government Department of Health (Medical Research Futures Fund)
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Address [1]
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Department of Industry, Science, Energy and Resources, GPO Box 2013, Canberra, ACT, 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Queensland
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Address
University of Queensland
St Lucia, Brisbane, Queensland. 4072
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
310044
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Country [1]
310044
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Brisbane and Women's Hospital HREC
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Ethics committee address [1]
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Level 2, Building 34 Butterfield st Royal Brisbane & Women’s Hospital Herston Qld 4029
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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02/07/2021
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Approval date [1]
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04/08/2021
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Ethics approval number [1]
308964
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Summary
Brief summary
The aim of this study is to use whole genome sequencing technology to define the genetic variations present within a breast cancer patient’s tumour, prior to treatment. This information will be used to determine whether we could predict whether different therapies could elicit an improved response should the tumour not respond to the first round of drugs or if it recurs or spreads some time after initial treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned for treatment via a neo-adjuvant pathway. Study details Prior to starting neoadjuvant therapy, all participants will have a core biopsy taken by a qualified radiologist and give a blood sample. After neoadjuvant treatment is complete, participants will undergo their planned surgery, where a sample of the resected tumour will may be taken (if the treatment has not been completely effective). Samples will be analysed via whole genome sequencing. We will also be analysing patient blood for circulating tumour DNA and circulating tumour cells in order to predict treatment response and recurrence. A detailed health economics analysis will also take place to determine if whole genome sequencing offers a cost effective benefit to patients and the health system. It is hoped that this study will demonstrate that whole genome sequencing technology can be used to identify genetic variations in breast cancer patients that could be targetable by drug therapies. This could help to justify personalising breast cancer therapy based on whole genome sequencing analysis in future.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sunil Lakhani
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Address
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UQ Centre for Clinical Research (UQCCR) Level 6, Building 71/918, Bowen Bridge Rd Royal Brisbane and Women’s Hospital, Herston QLD 4029
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Country
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Australia
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Phone
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+61 7 3346 6052
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Amy McCart Reed
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Address
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UQ Centre for Clinical Research (UQCCR) Level 6, Building 71/918, Bowen Bridge Rd Royal Brisbane and Women’s Hospital, Herston QLD 4029
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Country
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Australia
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Phone
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+61 07 33466030
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Amy McCart Reed
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Address
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UQ Centre for Clinical Research (UQCCR) Level 6, Building 71/918, Bowen Bridge Rd Royal Brisbane and Women’s Hospital, Herston QLD 4029
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Country
112500
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Australia
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Phone
112500
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+61 07 33466030
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Fax
112500
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Email
112500
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Researchers will the skills to access the data
Conditions for requesting access:
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-
What individual participant data might be shared?
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The de-identified genomic sequencing data will be provided when the data is published
What types of analyses could be done with individual participant data?
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For further genome data analysis
When can requests for individual participant data be made (start and end dates)?
From:
The data will be made available as per the conditions of publication of any manuscript
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
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The data will be released to human genome data repositories such as European Genome-phenome Archive.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
[email protected]
Informed consent form
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The Queensland IMplementation of PRecision Oncology in brEast cancer (Q-IMPROvE) pilot study.
2023
https://dx.doi.org/10.5694/mja2.51900
N.B. These documents automatically identified may not have been verified by the study sponsor.
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