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Trial registered on ANZCTR


Registration number
ACTRN12618000735257
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
2/05/2018
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
iTestis: Development of a detailed database for collection of clinical data in patients with testicular cancer
Scientific title
iTestis: Development of a detailed database for collection of clinical data in patients with testicular cancer
Secondary ID [1] 294064 0
None
Universal Trial Number (UTN)
Trial acronym
iTestis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
testicular cancer 306620 0
Condition category
Condition code
Cancer 305723 305723 0 0
Testicular

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Years
Description of intervention(s) / exposure
The follow-up period is 4 years. No additional tests are required, all data will be collected from the medical record of patients with histologically or cytologically confirmed Germ Cell Tumour. Data captured will include presentation and disease characteristics, patient characteristics, local and systemic therapies, surveillance methods, recurrence data and treatment outcomes.
Intervention code [1] 300338 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304799 0
Proportion of patients diagnosed with Germ Cell Tumour (GCT) in Australia that are recurrence-free after treatment. This outcome is being assessed from each patient's medical record,
Timepoint [1] 304799 0
End of 4 year data collection period. Data will be collected at up to 6 timepoints:
Diagnosis
Surgery
Surveillance
Chemotherapy
Radiotherapy
Recurrence
Secondary outcome [1] 345903 0
Overall survival of patients diagnosed with Germ Cell Tumour (GCT) in Australia after treatment. This outcome is being assessed from each patient's medical record,
Timepoint [1] 345903 0
End of 4 year data collection period. Data will be collected at up to 6 timepoints:
Diagnosis
Surgery
Surveillance
Chemotherapy
Radiotherapy
Recurrence

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed GCT (non-seminoma or seminoma); or exceptionally raised tumour markers (AFP greater then or equal to 1000ng/mL and/or HCG greater than or equal to 5000 IU/L) without histological or cytological confirmation in the rare case where biopsy may not be feasible.
Primary arising in testis, retro-peritoneum, or mediastinum.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics will be used when comparing clinical characteristics between groups. Chi-square or Fisher’s test will be used to test associations. The Kaplan-Meir method will be used for survival analyses. Regression analysis may also be used in univariate and multivariate analysis for relevant associations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 10033 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 10034 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 10035 0
Western Hospital - Footscray - Footscray
Recruitment hospital [4] 10036 0
Epworth Freemasons - Melbourne
Recruitment hospital [5] 10037 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 10038 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 14166 0
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [8] 14167 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [9] 14168 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [10] 14169 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 19376 0
3050 - Parkville
Recruitment postcode(s) [2] 19377 0
3000 - Melbourne
Recruitment postcode(s) [3] 19378 0
3011 - Footscray
Recruitment postcode(s) [4] 19379 0
3002 - Melbourne
Recruitment postcode(s) [5] 19380 0
3084 - Heidelberg
Recruitment postcode(s) [6] 19381 0
3128 - Box Hill
Recruitment postcode(s) [7] 27136 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 27137 0
3065 - Fitzroy
Recruitment postcode(s) [9] 27138 0
2305 - New Lambton Heights
Recruitment postcode(s) [10] 27139 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 298691 0
Other Collaborative groups
Name [1] 298691 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address [1] 298691 0
Level 6 Lifehouse Building
119-143 Missenden Road Camperdown NSW 2050
Country [1] 298691 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Walter and Eliza Hall Institute for Medical Research
Address
1G Royal Parade
Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 297862 0
None
Name [1] 297862 0
Address [1] 297862 0
Country [1] 297862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299643 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299643 0
Royal Melbourne Hospital
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 299643 0
Australia
Date submitted for ethics approval [1] 299643 0
29/11/2017
Approval date [1] 299643 0
12/01/2018
Ethics approval number [1] 299643 0
HREC/17/MH/400

Summary
Brief summary
iTestis is a detailed database that will allow the collection of high quality clinical data in patients with Germ Cell Tumour.
Who is it for?
You may be eligible for this study if you have confirmed germ-cell tumor arising primarily in the testes, retro-peritoneum or mediastinum.
Study details
All enrolled patients will contribute data to the development of the web database. Data captured will include presentation and disease characteristics, patient characteristics, local and systemic therapies, surveillance methods, recurrence data and treatment outcomes. Data will be collected for up to 4 years and will be updated regularly by study personnel throughout the patient’s treatment and follow-up from their medical record.
It is hoped this study will will help to describe the current care and treatment patterns for GCT patients and identify any deficiencies or abnormalities to ensure that Australian GCT patients receive the best care possible.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81146 0
Dr Ben Tran
Address 81146 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne Vic 3000
Country 81146 0
Australia
Phone 81146 0
+61 3 8559 7810
Fax 81146 0
+61 3 8559 7739
Email 81146 0
ben.tran@petermac.org.au
Contact person for public queries
Name 81147 0
Dr Ben Tran
Address 81147 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne Vic 3000
Country 81147 0
Australia
Phone 81147 0
+61 3 8559 7810
Fax 81147 0
+61 3 8559 7739
Email 81147 0
ben.tran@petermac.org.au
Contact person for scientific queries
Name 81148 0
Dr Ben Tran
Address 81148 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne Vic 3000
Country 81148 0
Australia
Phone 81148 0
+61 3 8559 7810
Fax 81148 0
+61 3 8559 7739
Email 81148 0
ben.tran@petermac.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD may be collected at a site level. However, IPD will not be made available to the Sponsor. The data that is collected by the Sponsor will not be re-identifiable at the Sponsor level. There are safeguards in place to minimise the risk of a privacy breach. They include analysing the data on an aggregated level and access to the data in a controlled environment with only authorised study personnel. Finally, enabling the availability of IPDs will not help meet the primary and secondary objectives of the study which are dependent on the results from the study population rather than on an individual basis.
What supporting documents are/will be available?
No other documents available
Summary results
No Results