Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000221550
Ethics application status
Approved
Date submitted
10/02/2015
Date registered
9/03/2015
Date last updated
14/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Australasian Oncofertility Registry: uptake and utilisation of fertility preservation, reproductive health after cancer treatment, and future use and complications of assisted reproductive technologies in cancer survivors
Scientific title
Australasian Oncofertility Registry: uptake and utilisation of fertility preservation, reproductive health after cancer treatment, and future use and complications of assisted reproductive technologies in cancer survivors
Secondary ID [1] 286138 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
AOFR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility Preservation in cancer patients 294146 0
Sexual health in cancer patients 294147 0
Sexual dyfunction in cancer patients 294231 0
Assisted reproduction treatment (ART) in cancer patients 294232 0
Condition category
Condition code
Cancer 294466 294466 0 0
Any cancer
Reproductive Health and Childbirth 294688 294688 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
20
Target follow-up type
Years
Description of intervention(s) / exposure
This project will establish the first web-based, multi-site Australasian Oncofertility Registry (AOFR) collecting data from cancer and fertility specialists. Outcomes generated from the study will provide meaningful translational data regarding uptake and utilisation of fertility preservation, future use and complications of assisted reproductive technologies as well as the potential for infertility following treatment for cancer survivors. The data from the registry and patient Medicare records will be used to perform a cost modeling health economics study.
The research study will be undertaken under five broad and interlinked themes. These themes include:
Themes 1: Awareness and referral for fertility preservation
Theme 2: Strategies, uptake, complications and quality of fertility preservation in cancer patients
Theme 3: Reproductive health following cancer treatment
Theme 4: Family planning and use of assisted reproductive technologies with pregnancy and birth outcomes
Theme 5: Health service utilisation and cost of fertility preservation programs for cancer patients in Australasia
Patients will be followed for a 20 year period to ensure that data on theme 3 and 4 can be captured.
Cancer survivors patients will be asked to consent to the research team collecting follow up data on patients fertility potential. For male patients this includes blood tests and semen analysis in year 1, 3 and 5 after cancer treatment. For female patients this includes blood tests and an ultrasound scan looking at follicle count annually.

Cancer patients that will be enrolled retrospectively from the previous two years - calendar years 2014-2016. Patient Medical Records will be accessed to undertake a retrospective review of eligible patient demographics, cancer details, treatment protocol, blood tests and scan results.
Intervention code [1] 291138 0
Not applicable
Comparator / control treatment
No control group to be studied
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294251 0
Themes 1: Awareness and referral for fertility preservation

The outcome is assessed directly by data in the AOFR by descriptive statistics such as means, standard deviations, medians and inter quartile ranges for the variables and frequency distrubutions will be used to describe characteristics associated with a patients diagosis and referral for FP.
Timepoint [1] 294251 0
Data for this outcome will be captured at diagnosis. Data will be collected prospectively at diagnosis for all patients as well as patients that were unable to be captured prospectively at the time of diagnosis, the FUTuRE Fertility research group have decided to retrospectively go back two years to capture patients onto the Registry. This will enable the research team to capture greater numbers of patients diagnosed with cancer, accessing fertility preservation, onto the Registry.
The outcome is assessed by descriptive statistics such as means, standard deviations, medians and inter quartile ranges for the variables and frequency distributions will be used to describe characteristics associated with a patients diagnosis and referral for FP.
Primary outcome [2] 294329 0
Theme 2: Fertility preservation uptake

The outcome is assessed directly by data in the AOFR:
Semi-parametric regression will be used to assess the trends in uptkae of FP and stratified by age and gender. Univariable and multivariable logist regression models will be used to determine the independent predictors of the prevalence for fertility preservation over time throughout Australia.
Timepoint [2] 294329 0
Data for this outcome will be captured prospectively at a number of time points: 1. Diagnosis prior to treatment 2. Following cancer diagnosis in the first 5 years 3. At diagnosis of relapse prior to treatment 4. Following cancer treatment in the first 5 years.
Data will be collected prospectively at diagnosis for all patients
For cancer patient's enrolled retrospectively onto the Registry, their Medical Record will be accessed. Eligible patients to be enrolled retrospectively will be two years from date of diagnosis.
The outcome is assessed by: Semi-parametric regression will be used to assess the trends in uptake of FP and stratified by age and gender. Univariable and multivariable logist regression models will be used to determine the independent predictors of the prevalence for fertility preservation over time throughout Australia.
Primary outcome [3] 294330 0
Theme 3: Reproductive health following cancer treatment

The outcome is assessed directly by data in the AOFR:
Kaplain Meir survival analysis and Cox proportional regression models will be used to identify the factors associated with the time to return to normal reproductive function.


Timepoint [3] 294330 0
Data for this outcome will be captured annually from the end of treatment for the next 5 years.

The outcome is assessed by:
Kaplain Meir survival analysis and Cox proportional regression models will be used to identify the factors associated with the time to return to normal reproductive function.


Secondary outcome [1] 312875 0
Theme 4: Family planning and use of assisted reproductive technologies after cancer diagnosis

Method of assessment - Data collected on the registry ( natural or ART pregnancy, complication rates during ART, pregnancy, perinatal and neonatal outcomes).

The data is collected prospectively by the clinical team completing the registry form for a patient online or paper record. Patients consent to notes being reviewed for the purpose of ensuring a complete data set is collected and the notes will be reviewed if necessary by CRA staff.
Timepoint [1] 312875 0
Data will be collected prospectively annually for all cancer patients on the AOFR for 20 years
Secondary outcome [2] 313055 0
Theme 5: Health service utilisation and cost of fertility

Method of assessment - linkage to Medicare item numbers
Timepoint [2] 313055 0
Data for this outcome will be collected at the time of fertility preservation which may happen at diagnosis or in the 5 years following a cancer diagnosis

Eligibility
Key inclusion criteria
Update
Registry patient inclusion criteria
a. All patients (any cancer diagnosis) diagnosed with cancer
b. Cancer patients aged 13-45 who diagnosed with cancer
c. Cancer patients aged 0-12 years of age who are referred for fertility preservation only.
Those paediatric patients who are not referred for FP will not be eligible.
d. All retrospective patients within two years from diagnosis
Minimum age
No limit
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Registry patient exclusion criteria
a. Non-cancer patients who are treated with gonadotoxic drugs will not be registered in phase 1.
b. Parents/siblings who undergo fertility preservation for a child/sibling.
c. Patients who do not consent to data being collected and reported.
d. Patients whose first language is not English when we cannot get an appropriate interpreter to provide consent for the study.
e. Patients who do not consent or assent to the registry
f. Patients who do not have cancer
g. Patients who are not of child bearing age

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics such as means, standard deviations, medians, inter-quartile ranges (for the continuous variables) and frequency distributions (for the categorical variables) will be used to describe characteristics associated with a cancer patient's diagnosis, acquisition of fertility preservation and ART.

New novel statistical techniques such as semi-parametric regression will be used to assess the trends in uptake of fertility preservation (after a cancer diagnosis) over the years which will be stratified by age and gender. Univariable and multivariable logistic regression models will be used to determine the independent predictors of the prevalence for fertility preservation and over the years in Australia.

Kaplan –Meir survival analysis and Cox proportional regression models will be used to identify the factors associated with time to return to normal reproductive function. Health economic strategies will be evaluated using a Markov decision model to conduct and compare the costs of FP strategies for cancer survivors

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/07/2015
Actual
8/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6641 0
New Zealand
State/province [1] 6641 0
Christchurch
Country [2] 6642 0
New Zealand
State/province [2] 6642 0
Auckland

Funding & Sponsors
Funding source category [1] 290708 0
Charities/Societies/Foundations
Name [1] 290708 0
Salesforce Australia Foundation
Country [1] 290708 0
Australia
Funding source category [2] 290709 0
Hospital
Name [2] 290709 0
Kids Cancer Centre, Sydey Children's Hospital
Country [2] 290709 0
Australia
Funding source category [3] 290710 0
Charities/Societies/Foundations
Name [3] 290710 0
CanTeen Australia
Country [3] 290710 0
Australia
Funding source category [4] 290711 0
Charities/Societies/Foundations
Name [4] 290711 0
Fertility Society of Australia
Country [4] 290711 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney NSW 2052, Australia
Country
Australia
Secondary sponsor category [1] 289400 0
None
Name [1] 289400 0
Address [1] 289400 0
Country [1] 289400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292342 0
South Eastern Sydney Local Health District
Ethics committee address [1] 292342 0
Prince of Wales Hospital
High Street Randwick
Sydney
NSW
2031
Ethics committee country [1] 292342 0
Australia
Date submitted for ethics approval [1] 292342 0
Approval date [1] 292342 0
27/11/2014
Ethics approval number [1] 292342 0
14/245
Ethics committee name [2] 292349 0
Tasmanian Human Research Ethics Committee
Ethics committee address [2] 292349 0
Lauren Black
Executive Officer - Ethics
Office of Research Services
University of Tasmania
Private Bag 01
Hobart TAS 7001
Ethics committee country [2] 292349 0
Australia
Date submitted for ethics approval [2] 292349 0
Approval date [2] 292349 0
10/02/2015
Ethics approval number [2] 292349 0
H0014609
Ethics committee name [3] 292350 0
Royal Children's Hospital Melbourne Ethics
Ethics committee address [3] 292350 0
Royal Children's Hospital Melbourne
50 Flemington Road
Parkville
Victoria
3052
Ethics committee country [3] 292350 0
Australia
Date submitted for ethics approval [3] 292350 0
05/01/2015
Approval date [3] 292350 0
Ethics approval number [3] 292350 0
HREC/15/RCHM/1
Ethics committee name [4] 292351 0
ACT Health Human Research Ethics Committee
Ethics committee address [4] 292351 0
Ms August Marchesi
Building 10
Level 6
Canberra Hospital
1 Woden
ACT
2606
Ethics committee country [4] 292351 0
Australia
Date submitted for ethics approval [4] 292351 0
Approval date [4] 292351 0
12/01/2015
Ethics approval number [4] 292351 0
ETH.11.14.322
Ethics committee name [5] 292352 0
Princess Margaret Hospital
Ethics committee address [5] 292352 0
Ms Jenny Westgarth- Taylor
Level 1, CCRF, Princess Margaret Hospital
Roberts Road,
Subiaco
WA
6008
Ethics committee country [5] 292352 0
Date submitted for ethics approval [5] 292352 0
Approval date [5] 292352 0
05/01/2015
Ethics approval number [5] 292352 0
2015001EP
Ethics committee name [6] 292353 0
The Women's and Children's Hospital
Ethics committee address [6] 292353 0
72 King William Road
North Adelaide
South Australia
5006
Ethics committee country [6] 292353 0
Australia
Date submitted for ethics approval [6] 292353 0
05/01/2015
Approval date [6] 292353 0
Ethics approval number [6] 292353 0
Ethics committee name [7] 292355 0
The Lady Cilento Children's Hospital
Ethics committee address [7] 292355 0
501 Stanly Street
South Brisbane
Queensland 4101
Ethics committee country [7] 292355 0
Australia
Date submitted for ethics approval [7] 292355 0
05/01/2015
Approval date [7] 292355 0
Ethics approval number [7] 292355 0
Ethics committee name [8] 292356 0
Genea Fertility
Ethics committee address [8] 292356 0
Wendy Bradford, Level 2, 321 Kent Street Sydney NSW 2000
Ethics committee country [8] 292356 0
Australia
Date submitted for ethics approval [8] 292356 0
Approval date [8] 292356 0
17/12/2014
Ethics approval number [8] 292356 0
GEC0019

Summary
Brief summary
This study will establish the first web-based, multi-site Australasian Oncofertility Registry (AOFR) collecting data from cancer and fertility specialists. This study is for cancer patients who are diagnosed with cancer who are aged under 45 years old.

Who is it for?
You may be eligible to join this study if you are aged 13 years or above and have been diagnosed with cancer or aged 0-12 years diagnosed with cancer who have been referred for fertility preservation only.

Study Details
This study will collect data regarding uptake and utilisation of fertility preservation, future use and complications of assisted reproductive technologies as well as the potential for infertility following treatment for cancer survivors will be collected. Patients will be asked to consent to the research team collecting the results of fertility tests following cancer treatment. In males (semen analysis and fertility hormone blood tests in years 1,3,5). In females fertility hormone blood tests and ultrasound scans looking at the number of follicles in the ovaries.

The research study will be undertaken under five broad and interlinked themes. These themes include: Themes 1: Awareness and referral for fertility preservation Theme 2: Strategies, uptake, complications and quality of fertility preservation in cancer patients Theme 3: Reproductive health following cancer treatment Theme 4: Family planning and use of assisted reproductive technologies with pregnancy and birth outcomes
The data from the registry and patient Medicare records will be used to perform a cost modeling health economics study for theme.
Patients who consent to being part of the AOFR study wil be asked to supply data at diagnosis, end of treatment and then annually for 20 years.

Eligible patients or their parents/guardians/carers on behalf of the patient no longer being treated for their cancer at their cancer centre will be contacted retrospectively (2 years retrospectively from diagnosis) by the International FUTuRE Fertility Research Manager to explain the study and to determine whether eligible patients or parent/guardian/carer on behalf of their child would be interested in having their/their child's details stored on the registry. If a patient or parent/carer/guardian on behalf of the patient, is interested in having their/their child's Medical records reviewed in order to ascertain personal, cancer and fertility history then an information pack will be sent out to the patient/patient's family. The information pack will include study information details and patient consent forms.
Trial website
www.futurefertility.com.au
Trial related presentations / publications
Public notes
Attachments [1] 304 304 0 0
/AnzctrAttachments/367933-Future Fertility protocol 28_7_14.docx

Contacts
Principal investigator
Name 54790 0
Dr Antoinette Catherine Anazodo
Address 54790 0
Sydney Youth Cancer Service
Sydney Children's Hospital and Prince of Wales Hospital
High Street Randwick
Randwick
NSW
2031
Country 54790 0
Australia
Phone 54790 0
+61 (2) 93821733
Fax 54790 0
+61 (2) 93821789
Email 54790 0
[email protected]
Contact person for public queries
Name 54791 0
Mrs Brigitte Gerstl
Address 54791 0
National Project Manager
Kids Cancer Centre, Sydney Children's Hospital
High Street Randwick
Randwick
NSW
2031
Country 54791 0
Australia
Phone 54791 0
+61 (2) 9382 9287
Fax 54791 0
+61 (2) 93821789
Email 54791 0
[email protected]
Contact person for scientific queries
Name 54792 0
Dr Antoinette Catherine Anazodo
Address 54792 0
Sydney Youth Cancer Service
Sydney Children's Hospital and Prince of Wales Hospital
High Street Randwick
Randwick
NSW
2031
Country 54792 0
Australia
Phone 54792 0
+61 (2) 93821733
Fax 54792 0
+61 (2) 93821789
Email 54792 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
SourceTitleYear of PublicationDOI
EmbaseA study protocol for the australasian oncofertility registry: Monitoring referral patterns and the uptake, quality, and complications of fertility preservation strategies in Australia and New Zealand.2016https://dx.doi.org/10.1089/jayao.2015.0062
N.B. These documents automatically identified may not have been verified by the study sponsor.