Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000247774
Ethics application status
Approved
Date submitted
21/01/2022
Date registered
11/02/2022
Date last updated
28/02/2023
Date data sharing statement initially provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
CLIMATE: Assessing the Clinical utility of miR-371a-3p as a marker of residual disease in Clinical Stage 1 Testicular Germ Cell Tumour, following orchidectomy.
Scientific title
Assessing the Clinical utility of miR-371a-3p as a marker of residual disease in Clinical Stage 1 Testicular Germ Cell Tumour, following orchidectomy.
Secondary ID [1] 306238 0
ANZUP1906
Universal Trial Number (UTN)
Trial acronym
CLIMATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Germ Cell Tumour 324967 0
Testicular Cancer 324968 0
Condition category
Condition code
Cancer 322401 322401 0 0
Testicular

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients enrolled to the study will undergo active surveillance in accordance with the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group’s surveillance recommendations for clinical stage 1 seminoma or non-seminomatous germ cell tumours (NSGCT). Active surveillance requires attendance at face-to-face clinical appointments with an oncologist and involves physical examination, collection of blood samples, and CT of abdomen and pelvis at 6, 12, 18 and 24 months post orchidectomy (seminoma) or CT of abdomen and pelvis and chest x-ray at 4, 8, 12, 18 and 24 months post orchidectomy (NSGCT). Blood samples, for miR-371, will be collected at various time points (within 6 weeks of orchidectomy, at 3, 6, 9, 12, 15, 18, 21 and 24 months post orchidectomy) or until relapse, whichever occurs first. Blood for study purposes will be collected at the same time as standard of care blood is taken for tumour markers and will be collected by a suitably qualified staff member. Clinical and outcome data from the participant's medical record will be collected for 5 years and there is no requirement to attend any additional appointments for this to occur.
Intervention code [1] 322644 0
Diagnosis / Prognosis
Intervention code [2] 322740 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330163 0
Estimate the negative predictive value (NPV) and positive predictive value (PPV) of post-orchidectomy plasma miR-371 in predicting clinically confirmed relapse within 12 months as determined by existing clinical instruments used to detect relapse, including serum tumour biomarkers and radiologic evaluation, where applicable.
Timepoint [1] 330163 0
Data will be collected within 6 weeks post orchidectomy, and at 3, 6, 9, 12, 15, 18, 21, and 24 months post orchidectomy or until relapse, whichever occurs first. The primary timepoint is 12 months.
Secondary outcome [1] 405093 0
Estimate the specificity of serum miR-371 at time of relapse by comparing to existing clinical instruments used to detect relapse, including serum tumour biomarkers and radiologic evaluation, where applicable.
Clinical outcome data will be collected for five years, however frequency and method of assessment is not prescribed by CLIMATE. Instead, clinical evaluation as per the clinicians' usual practice should continue. Any episodes of relapse will be documented.
Timepoint [1] 405093 0
This will be assessed at the time of relapse or up to 24 months post orchidectomy, which ever occurs first.
Secondary outcome [2] 405987 0
Estimate the sensitivity of serum miR-371 at time of relapse by comparing to existing clinical instruments used to detect relapse, including serum tumour biomarkers and radiologic evaluation, where applicable.
Clinical outcome data will be collected for five years, however frequency and method of assessment is not prescribed by CLIMATE. Instead, clinical evaluation as per the clinicians' usual practice should continue. Any episodes of relapse will be documented.
Timepoint [2] 405987 0
This will be assessed at the time of relapse or up to 24 months post orchidectomy, which ever occurs first.

Eligibility
Key inclusion criteria
1. Histologically confirmed testicular germ cell tumour confirmed by prior orchidectomy no more than 12 weeks before study enrolment.
2. Clinical stage 1 testicular germ cell tumour and planned for active surveillance and no adjuvant chemotherapy.
3. Patient willing to undergo active surveillance.
4. Capable of giving written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Extragonadal, i.e. retroperitoneal or mediastinal, germ cell tumour
2. Evidence of advanced or metastatic disease on imaging, i.e. computerised tomography, magnetic resonance imaging or positron emission tomography (as clinically indicated).
3. Previous diagnosis of testicular germ cell tumour, i.e. contralateral testis, excluding the disease under study.
4. Known medical condition or other issue that in the opinion of the investigator, that would affect adherence to study requirements

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to describe the objectives:
• To estimate the negative predictive value (NPV) and positive predictive value (PPV) of miR-371 in predicting relapse within 12 months.
• To estimate the sensitivity and specificity of serum miR-371 at time of relapse.
• Clinically-confirmed relapse, or a true positive miR-371 result, will be defined by progressive radiological change or response to appropriate therapy, progressive tumour marker elevation or definitive histopathology.
Multiple regression analyses will be used to identify baseline clinicopathological features associated with relapse.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
25/02/2022
Date of last participant enrolment
Anticipated
14/02/2025
Actual
Date of last data collection
Anticipated
14/02/2027
Actual
Sample size
Target
200
Accrual to date
49
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 21499 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 21500 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [3] 21501 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 21502 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [5] 21503 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 21504 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment hospital [7] 21505 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 21506 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [9] 21509 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [10] 21510 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [11] 24150 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 36415 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 36408 0
2050 - Camperdown
Recruitment postcode(s) [3] 36416 0
2076 - Wahroonga
Recruitment postcode(s) [4] 36407 0
2298 - Waratah
Recruitment postcode(s) [5] 36411 0
3000 - Melbourne
Recruitment postcode(s) [6] 36410 0
3002 - East Melbourne
Recruitment postcode(s) [7] 36405 0
3084 - Heidelberg
Recruitment postcode(s) [8] 36409 0
3128 - Box Hill
Recruitment postcode(s) [9] 36406 0
3220 - Geelong
Recruitment postcode(s) [10] 36412 0
4029 - Herston
Recruitment postcode(s) [11] 39661 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 310585 0
Charities/Societies/Foundations
Name [1] 310585 0
ANZUP
Country [1] 310585 0
Australia
Funding source category [2] 310586 0
Other Collaborative groups
Name [2] 310586 0
Walter and Eliza Hall Institute of Medical Research
Country [2] 310586 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
ANZUP
Address
Lifehouse, Level 6, 119-143 Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311774 0
None
Name [1] 311774 0
Address [1] 311774 0
Country [1] 311774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310191 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 310191 0
Level 2 South West, 300 Grattan Street, Parkville Victoria 3052
Ethics committee country [1] 310191 0
Australia
Date submitted for ethics approval [1] 310191 0
30/06/2021
Approval date [1] 310191 0
25/08/2021
Ethics approval number [1] 310191 0
HREC/77002/MH-2021

Summary
Brief summary
CLIMATE is an observational study which aims to see if additional blood sampling during active surveillance (no additional treatment) following surgery (orchidectomy) in patients with testicular germ cell cancer may help predict the risk of the cancer recurring.

Who is it for?
You may be eligible for this study if you are a male 18 years or older and you have been diagnosed with a clinical stage 1 testicular germ cell tumour, and are recommended for active surveillance following your recent surgery.

Study details
All participants will receive active surveillance for 2 years post-enrolment in accordance with the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group’s surveillance recommendations for clinical stage 1 seminoma or non-seminomatous germ cell tumour. Active surveillance requires attendance at face-to-face clinical appointments with an oncologist and involves physical examination, the collection of blood samples within 6 weeks of orchidectomy and at 3, 6, 9, 12, 15, 18, 21 and 24 months post orchidectomy, as well as a CT of abdomen and pelvis at 6, 12, 18 and 24 months post orchidectomy (seminoma) or CT of abdomen and pelvis and chest x-ray at 4, 8, 12, 18 and 24 months post orchidectomy (NSGCT). Blood samples to assess miR-371 will be collected at various time points (within 6 weeks of orchidectomy, at 3, 6, 9, 12, 15, 18, 21 and 24 months post orchidectomy) or until relapse, whichever occurs first. Blood for study purposes will be collected at the same time as standard of care blood is taken for tumour markers. Assessment of miR-371 levels in the blood will be compared to the findings of active surveillance to determine if it is an accurate marker of disease relapse.

It is hoped that this study may show that miR-371 levels are able to predict disease relapse, which may help to guide decision-making following surgery in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116814 0
A/Prof Ben Tran
Address 116814 0
Medical Oncology Peter MacCallum Cancer Centre 305 Grattan St Melbourne Vic 3000
Country 116814 0
Australia
Phone 116814 0
+61 3 8559 7810
Fax 116814 0
+61 3 8559 7739
Email 116814 0
ben.tran@petermac.org.au
Contact person for public queries
Name 116815 0
A/Prof Ben Tran
Address 116815 0
Medical Oncology Peter MacCallum Cancer Centre 305 Grattan St Melbourne Vic 3000
Country 116815 0
Australia
Phone 116815 0
+61 3 8559 7810
Fax 116815 0
+61 3 8559 7739
Email 116815 0
ben.tran@petermac.org.au
Contact person for scientific queries
Name 116816 0
A/Prof Ben Tran
Address 116816 0
Medical Oncology Peter MacCallum Cancer Centre 305 Grattan St Melbourne Vic 3000
Country 116816 0
Australia
Phone 116816 0
+61 3 8559 7810
Fax 116816 0
+61 3 8559 7739
Email 116816 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


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.