Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000931279
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
1/06/2018
Date last updated
5/07/2022
Date data sharing statement initially provided
26/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying and validating predictive and prognostic biomarkers in male Germ Cell Tumours to improve the management and outcomes in both stage 1 and disseminated disease.
Scientific title
Assessing Predictive and Prognostic Biomarkers in Germ Cell Tumours - Testis
Secondary ID [1] 294052 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Germ Cell Tumour (GCT) 306602 0
Seminoma 306720 0
Testicular cancer 306721 0
Condition category
Condition code
Cancer 305696 305696 0 0
Testicular

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Enrolled patients diagnosed with germ cell tumours will donate a sample of tissue taken during their previous and or future surgery and or biopsy and information will be collected regarding their general health, the type of cancer treatments they have had, how their cancer responded to the treatment, any side effects from the treatment, and other personal details such as age. Additionally, they will be asked to donate blood samples, up to 50ml (2 to 3 tablespoons), for research purposes on the following occasions:
• Before and after surgical removal of their germ cell tumour (if applicable)
• Before and after any chemotherapy regimen (if applicable)
• Every 6 months while on active surveillance (if applicable)
We will try to ensure that the collection of bloods for research will be done at the same time as blood collections for tests that patients would otherwise have as part of routine care.
Overall duration of follow-up for each study participant is 10 years or loss to follow-up.
Intervention code [1] 300327 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304787 0
Proportion of patients with stage 1 seminoma and non-seminoma that relapse as assessed from each patient's medical record.
Timepoint [1] 304787 0
Primary timepoint is the end of 10 year data collection and molecular analyses of archival tumour specimens and blood collections,
Secondary outcome [1] 343190 0
Number of prognostic biomarkers for stage 1 seminoma identified and validated. This is an exploratory outcome. Molecular analyses of archival tumour specimens and blood will be performed using many different techniques, including next generation sequencing (NGS) for gene mutations or changes in copy number, in-situ hybridisation techniques or comparative genomic hybridization (CGH) for gene amplification, multiplexed microarrays or quantitative PCR for changes in gene expression and immunohistochemistry for changes in protein expression. Using multivariate analyses will allow for detection of prognostic biomarkers while minimising impact of selection and information biases.
Timepoint [1] 343190 0
Timepoint is the end of 10 year data collection and molecular analyses of archival tumour specimens and blood collections,
Secondary outcome [2] 343191 0
Number of prognostic biomarkers for stage 1 non-seminoma identified and validated. This is an exploratory outcome. Molecular analyses of archival tumour specimens and blood will be performed using many different techniques, including next generation sequencing (NGS) for gene mutations or changes in copy number, in-situ hybridisation techniques or comparative genomic hybridization (CGH) for gene amplification, multiplexed microarrays or quantitative PCR for changes in gene expression and immunohistochemistry for changes in protein expression. Using multivariate analyses will allow for detection of prognostic biomarkers while minimising impact of selection and information biases.
Timepoint [2] 343191 0
Timepoint is the end of 10 year data collection and molecular analyses of archival tumour specimens and blood collections,

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed GCT (non-seminoma or seminoma); or exceptionally raised tumour markers (AFP greater than or equal to 1000ng/mL and/or HCG greater than or equal to 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently.
Primary arising in testis, retro-peritoneum, or mediastinum.
Able to be accessible for follow-up and data collection.
Written, voluntary and informed consent.
Able to undergo collection of blood specimens.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No archival tissue specimen available.
Patient not accessible for follow up and data collection.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics will be used to analyse data arising directly from this protocol study. The Kaplan-Meier method and the Mantel-Cox log-rank test will be used for survival analyses. Proportions will be compared using the Chi square method or Fisher’s exact test. For all analyses, two-sided p values of < 0.05 were considered significant. Multivariate survival analyses will use the Cox Proportional Hazards method.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
800
Accrual to date
106
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10023 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 10024 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 10025 0
Western Hospital - Footscray - Footscray
Recruitment hospital [4] 10026 0
Epworth Freemasons - Melbourne
Recruitment hospital [5] 14102 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [6] 14103 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 19349 0
3050 - Parkville
Recruitment postcode(s) [2] 19350 0
3000 - Melbourne
Recruitment postcode(s) [3] 19351 0
3011 - Footscray
Recruitment postcode(s) [4] 19352 0
3002 - Melbourne
Recruitment postcode(s) [5] 26893 0
3065 - Fitzroy
Recruitment postcode(s) [6] 26894 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298677 0
Other Collaborative groups
Name [1] 298677 0
Walter and Eliza Hall Institute for Medical Research
Country [1] 298677 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] 297849 0
None
Name [1] 297849 0
Address [1] 297849 0
Country [1] 297849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299631 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299631 0
Ethics committee country [1] 299631 0
Australia
Date submitted for ethics approval [1] 299631 0
23/11/2015
Approval date [1] 299631 0
16/12/2015
Ethics approval number [1] 299631 0
HREC/15/MH/354

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

Contacts
Principal investigator
Name 81102 0
Dr Ben Tran
Address 81102 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne Vic 3000
Country 81102 0
Australia
Phone 81102 0
+61 3 8559 7810
Fax 81102 0
+61 3 8559 7739
Email 81102 0
[email protected]
Contact person for public queries
Name 81103 0
Ben Tran
Address 81103 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne Vic 3000
Country 81103 0
Australia
Phone 81103 0
+61 3 8559 7810
Fax 81103 0
+61 3 8559 7739
Email 81103 0
[email protected]
Contact person for scientific queries
Name 81104 0
Ben Tran
Address 81104 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne Vic 3000
Country 81104 0
Australia
Phone 81104 0
+61 3 8559 7810
Fax 81104 0
+61 3 8559 7739
Email 81104 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
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 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.