Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000367549
Ethics application status
Approved
Date submitted
4/03/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective database for neuroendocrine cancer (NET) patients recommended for peptide radionuclide receptor therapy (PRRT): The New Zealand PRRT Database
Scientific title
A prospective database for neuroendocrine cancer (NET) patients recommended for peptide radionuclide receptor therapy (PRRT) in New Zealand: a clinical registry study with a focus on treatment and clinical outcomes.
Secondary ID [1] 311656 0
CTNZ-2019-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine cancer 333114 0
Peptide radionuclide receptor therapy (PRRT) 333115 0
Condition category
Condition code
Cancer 329802 329802 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Peptide Receptor Radionuclide Therapy (PRRT) is a highly targeted therapy for neuroendocrine tumour (NET) patients and was first available in NZ (as a national service) in July 2021. PRRT works by administering a radioactive isotope tagged onto a somatostatin analogue (e.g. octreotate), which binds to somatostatin receptors on the tumour cells. These tumour cells then absorb the radiation and are killed. This prospective database is focused on PRRT treatment and outcomes, and is anticipated to have ongoing follow-up.

This study will involve the collection of patient medical records that already exist as part of standard clinical care. This includes data points at multidisciplinary meeting (MDM), referral, first specialist appointment (FSA), each cycle, 3 months after course has ended, and regular future follow-up which is anticipated to be approximately biannually for 5-years (funding-dependent).
Intervention code [1] 328119 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337577 0
Disease-specific survival
Timepoint [1] 337577 0
Outcome assessment anticipated biannually for 5-years following treatment.
Primary outcome [2] 337721 0
PRRT treatment response
Timepoint [2] 337721 0
3 months after a patient's last cycle of PRRT.
Primary outcome [3] 337722 0
Toxicity from PRRT
Timepoint [3] 337722 0
All relevant toxicities will be captured that occur from the start of treatment to three months following end of treatment.
Secondary outcome [1] 432364 0
Quality of life
Timepoint [1] 432364 0
Completed during the same hospital admission as the date of administration, for each cycle of PRRT received (four cycles for induction course, or two cycles for maintenance course).
Secondary outcome [2] 432365 0
Performance status
Timepoint [2] 432365 0
Multidisciplinary meeting (MDM) where PRRT recommendation was confirmed, treatment referral, course start (date of administration of cycle 1) and course end (date of administration of cycle 4 for induction course, or cycle 2 for maintenance course). Note the specific timeframe, e.g. the number of weeks after NET diagnosis, is unique to each patient, and dependent on a patient's individual course of disease and treatment priority scoring.
Secondary outcome [3] 432968 0
PRRT treatment inequities assessment
Timepoint [3] 432968 0
Analysis of patients who are recommended for PRRT by the national NET MDM, who receive the treatment, who complete the full intended course of treatment, with outcome anticipated to be measured biannually for 5-years after treatment.

Eligibility
Key inclusion criteria
Diagnosis of neuroendocrine neoplasm and recommended for PRRT treatment by the national NET MDM.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of neuroendocrine neoplasm but deemed unsuitable for PRRT treatment as determined by NET MDM.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
1/05/2030
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26186 0
New Zealand
State/province [1] 26186 0

Funding & Sponsors
Funding source category [1] 315985 0
Charities/Societies/Foundations
Name [1] 315985 0
Philanthropic funding from a single donor
Country [1] 315985 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318132 0
None
Name [1] 318132 0
Address [1] 318132 0
Country [1] 318132 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314807 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314807 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 314807 0
New Zealand
Date submitted for ethics approval [1] 314807 0
27/09/2023
Approval date [1] 314807 0
11/10/2023
Ethics approval number [1] 314807 0
2023 EXP 15436

Summary
Brief summary
PRRT is a highly targeted therapy for NET patients and was first available in NZ (as a national service) in July 2021. At this stage, all PRRT for people with NETs is provided in Auckland. This study employs quality clinical data at the interface between quality patient care and service improvement and research. A high quality service needs to collect high quality data in order to learn and improve. Previous relevant work includes development of the retrospective New Zealand NETwork! Registry (NETR). This demonstrated firstly the extensive work to create and maintain a registry, and secondly, the complexities involved with NETs. These complexities included the changing diagnostic criteria and reporting guidelines, clinical community awareness, vast primary sites and histological types. The lessons from NETR confirmed the need for an accurate and available data source to inform clinicians who are treating these patients.

This study aims to establish Aotearoa’s first prospective database of NET patients recommended for PRRT, with a focus on treatment and clinical outcomes. The key objectives are focussed on: how data is brought into the database (piloting automated drawing of data fields from hospital systems); the database itself (governance and robust data field development); and how data and insights are extracted from the database (reporting PRRT outcomes from NZ patients, and development of an interactive data tool).
Trial website
https://www.cancertrialsnz.ac.nz/prrt/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132794 0
Dr Laird Cameron
Address 132794 0
The University of Auckland (Faculty of Medical and Health Sciences), Level 1, Building 505, 85 Park Road, Grafton, Auckland, 1023
Country 132794 0
New Zealand
Phone 132794 0
+64 9 373 7599
Fax 132794 0
Email 132794 0
[email protected]
Contact person for public queries
Name 132795 0
Braden Woodhouse
Address 132795 0
The University of Auckland (Faculty of Medical and Health Sciences), Level 1, Building 505, 85 Park Road, Grafton, Auckland, 1023
Country 132795 0
New Zealand
Phone 132795 0
+64 9 373 7599
Fax 132795 0
Email 132795 0
[email protected]
Contact person for scientific queries
Name 132796 0
Braden Woodhouse
Address 132796 0
The University of Auckland (Faculty of Medical and Health Sciences), Level 1, Building 505, 85 Park Road, Grafton, Auckland, 1023
Country 132796 0
New Zealand
Phone 132796 0
+64 9 373 7599
Fax 132796 0
Email 132796 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21790Ethical approval    387434-(Uploaded-04-03-2024-11-45-54)-Study-related document.pdf



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.