Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT06932458
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (\>18 years) with pure seminoma on radical orchiectomy specimen.
2. Initial CS I presentation with subsequent retroperitoneal relapse on surveillance, or de novo CS II at presentation.
3. Axial imaging of lymphadenopathy within 8 weeks of the date of RPLND
1. No more than 2 enlarged retroperitoneal lymph nodes, each no more than 3cm in the primary landing zones.
2. Suitable for proposed bilateral RPLND template
4. Serum tumour markers (alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), and lactate dehydrogenase (LDH)) must all be within normal limits within 2 weeks of planned RPLND
Exclusion Criteria:
1. Any condition deemed by the treating surgeon to pose an unacceptable risk for retroperitoneal lymph node dissection
2. Any non-seminoma component on the orchiectomy specimen.
3. AFP \>20 at any time point, pre- or post-orchiectomy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06932458
Study Brief:
Protocol Section:
NCT06932458