None listed
Conditions
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.
Interventions
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
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.
Sponsors
ANZUP
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed testicular germ cell tumour confirmed by prior orchidectomy no more than 6 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.
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
Outcome results
None listed