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:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT05345158
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed seminomatous testicular germ cell tumour with negative margins on radical orchiectomy
* Lymphadenopathy in the retroperitoneum: at least one lymph node ≤5cm in size (in the transverse plane) detected on contrast CT scan or MRI (CS IIA/B; or active surveillance relapse with CS IIA/B equivalent)
* CT Chest negative for metastasis
* Patients qualify for this trial under the following scenarios: (1) initial diagnosis of clinical or stage IIA/B disease or (2) recurrence after surveillance for clinical stage I disease
* Patients with serum tumour marker elevation are eligible if the elevated marker does not exceed the following cut-offs within 10 days of RPLND: AFP (\< 2.5 x ULN) and β-hCG (\<5 IU/L)
* Curative treatment with RPLND is intended
* Under the care of a uro-oncologist at Princess Margaret Cancer Centre
* Willing to comply with follow-up protocol
* Capable of providing informed consent
Exclusion Criteria:
* Retroperitoneal lymphadenopathy \>5cm in the transverse plane (CS IIC)
* Metastasis to distant lymph nodes or any organ (CS III)
* History of chemotherapy or radiotherapy to the retroperitoneum
* Patients with previous scrotal or retroperitoneal surgery for indication other than germ cell tumour
* Patients in reduced general condition, with uncontrolled intercurrent illnesses, or with life-threatening disease
* Patients with psychiatric illnesses that would limit compliance with study requirements
* Unsuitable for robotic surgery (determined by treating physician)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05345158
Study Brief:
Protocol Section:
NCT05345158