Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000871549
Ethics application status
Approved
Date submitted
10/08/2015
Date registered
21/08/2015
Date last updated
3/04/2024
Date data sharing statement initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Tissue Collection Substudy in Australia and New Zealand for the participants of ANZ 1501 POSNOC (POsitive Sentinel NOde Clearance) study.
Scientific title
ANZ 1501 POSNOC substudy: Collection of primary tumour tissue samples from women participating in the main POSNOC study for tissue banking purposes.
Secondary ID [1] 286855 0
-delete-
(see "linked study record")
Universal Trial Number (UTN)
Trial acronym
POSNOC
Linked study record
Protocol RD-5103-001-13 (POSNOC)
ISRCTN Registry ISRCTN54765244
ClinicalTrials.gov NCT02401685

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 295249 0
Condition category
Condition code
Cancer 295494 295494 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Primary breast tumour sample will be collected during surgery from all patients randomized to the main POSNOC study in Australia and New Zealand.

Main study: Protocol RD-5103-001-13 - A randomized controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes.

ISRCTN54765244
NCT02401685
Intervention code [1] 292022 0
Not applicable
Comparator / control treatment
N/A for Tissue Collection substudy.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295229 0
Collection of Primary Tumour sample for Tissue Banking purposes from all patients randomized to the main POSNOC study in Australia and New Zealand.
Timepoint [1] 295229 0
Primary breast surgery
Secondary outcome [1] 315121 0
N/A
Timepoint [1] 315121 0
N/A

Eligibility
Key inclusion criteria
Tumour samples will be collected from patients participating in the Main POSNOC study in Australia and New Zealand. Key Inclusion Criteria for POSNOC are as follows:

* 18 years or older
* Unifocal or multi-focal invasive tumour with lesion <=5 cm in its largest dimension, measured pathologically or for women who are randomised intra-operatively largest tumour diameter on mammogram or ultrasound (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
* At sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay)
* Fit for axillary treatment and adjuvant therapy
* Have given written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Tumour samples will be collected from patients participating in the Main POSNOC study in Australia and New Zealand. Key Exclusion Criteria for POSNOC are as follows:

* bilateral breast cancer
* more than 2 nodes with macrometastases
* neoadjuvant therapy for breast cancer
* previous axillary surgery on the same body side as the scheduled sentinel node biopsy
* not receiving adjuvant systemic therapy
* previous cancer less than 5 years previously or concomitant malignancy except: adequately treated basal or squamous cell carcinoma of the skin; adequately treated in situ carcinoma of the cervix; adequately treated in situ melanoma; contra- or ipsilateral in situ breast cancer.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2015
Actual
6/06/2016
Date of last participant enrolment
Anticipated
31/08/2021
Actual
13/07/2021
Date of last data collection
Anticipated
13/07/2026
Actual
Sample size
Target
250
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 6952 0
New Zealand
State/province [1] 6952 0

Funding & Sponsors
Funding source category [1] 291409 0
Government body
Name [1] 291409 0
National Health and Medical Research Council
Country [1] 291409 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 290083 0
Other Collaborative groups
Name [1] 290083 0
Derby Hospitals NHS Foundation Trust
Address [1] 290083 0
Uttoxeter New Road
Derby DE22 3NE
Country [1] 290083 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292957 0
Melbourne Health HREC
Ethics committee address [1] 292957 0
Ethics committee country [1] 292957 0
Australia
Date submitted for ethics approval [1] 292957 0
25/05/2015
Approval date [1] 292957 0
23/06/2015
Ethics approval number [1] 292957 0
HREC/15/MH/153

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47666 0
Prof Bruce Mann
Address 47666 0
c/- The Royal Women's Hospital
Suite 12, Department of Surgery
Grattan Street
Parkville VIC 3052
Country 47666 0
Australia
Phone 47666 0
+61 3 9347 6301
Fax 47666 0
Email 47666 0
[email protected]
Contact person for public queries
Name 47667 0
Corinna Beckmore
Address 47667 0
BCT
PO Box 283
The Junction NSW 2291
Country 47667 0
Australia
Phone 47667 0
+61 2 4925 5235
Fax 47667 0
Email 47667 0
[email protected]
Contact person for scientific queries
Name 47668 0
Bruce Mann
Address 47668 0
c/- The Royal Women's Hospital Suite 12, Department of Surgery Grattan Street Parkville VIC 3052
Country 47668 0
Australia
Phone 47668 0
+61 3 9347 6301
Fax 47668 0
Email 47668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This project is for tumour tissue collection only.

The tumour samples are to be used by researchers in the future to better understand the nature of breast cancer and how patients respond to treatment in this study. The precise projects for which this tissue will be used cannot be determined until the outcomes of the study are known.

Tissue collected for this project will not be released until after planned protocol analyses are completed. The tissue specimens are intended for use in projects that are likely to translate into improved outcomes for patients with breast cancer, either directly, or via future projects.

Patients will not be identified by name. The only identification of tissue will be by a patient study number, hospital or clinic number, patient initials and date of birth. All testing performed on tumour tissue will be performed anonymously. Tumour tissue will be stored indefinitely.


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.