nct04435756

Eligibility

Inclusion Criterea

• Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of human chorionic gonadotropin [HCG]/alpha-fetoprotein [AFP]). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible. Testicular non-germ cell tumors such as leydig cell tumors, lymphoma, sertoli cell tumors, sarcomas, and mesothelioma are not eligible for the study
• Patients must have stage I, IA, IB or IIA disease. Testicular nonseminoma stage IS disease is eligible. NOTE: Effective April 15, 2022, S1823 closed to the high risk of relapse group (except for nonseminoma stage IS). With revision #2, these patients are no longer eligible as new enrollments.
• Male patients with testicular cancer must have orchiectomy completed within 56 days prior to registration if surgical removal of the primary tumor is planned.
• Patients must be registered within 56 days after diagnosis and prior to initiation of a management plan and/or active interventional treatment for the disease. Management includes active surveillance (with imaging studies and classic markers) or active treatment (chemotherapy, retroperitoneal surgery, or therapeutic radiation therapy). Adjuvant treatments (chemotherapy, radiation therapy [RT], or primary retroperitoneal lymph node dissection [RPLND]) are allowed. Note: The “management plan” referred to here is the post-diagnosis management plan. In most cases of clinical stage I and clinical stage II testicular cancer, the diagnosis is made with the orchiectomy. After the orchiectomy, every patient is managed with surveillance, chemotherapy, more surgery or radiation or combinations thereof.
• Patients must be >= 18 years of age. NOTE: patients less than 18 years of age should be considered for direct enrollment in COG AGCT 1531.
• Patients must agree to submit required specimens for defined translational medicine studies. These specimens may be drawn at the same time as standard of care clinical blood draws in order to minimize blood draws in the participant. NOTE: Patients should be willing to return to their registering site, that is, the center performing surveillance for the duration of the study to ensure that specimens are timed to the registering site’s surveillance schedule. Telehealth visits are allowed for this study.
• Patients must be offered participation in specimen banking for future research. With patient’s consent, specimens must be submitted.
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Documentation of informed consent via remote consent is allowed. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations. NOTE: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution’s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Exclusion Criterea