Diagnostic Study of Patients With Stage I Testicular Cancer
Condition: Testicular Germ Cell Tumor
MeSH terms: Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of
      testicular cancer.

      PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage
      I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.
    

Detailed description: 
      OBJECTIVES:

        -  Use histopathological and immunohistological analysis of the primary testis tumor along
           with quantitative radiographic assessment to identify a subset of patients with clinical
           stage I nonseminomatous germ cell tumor of the testis who have a very low risk of
           metastasis.

        -  Compare these findings with other predictive models of risk of metastasis after
           orchiectomy in this group of patients.

      OUTLINE: Patients undergo primary retroperitoneal lymph node dissection (RPLND) or active
      surveillance as management of their disease. The choice of treatment is determined by the
      physician and the patient. Patients with pathologically positive resected lymph nodes may
      undergo treatment (observation or adjuvant chemotherapy) at investigator's discretion.

      All patients are tested by quantitative radiology and blood markers (HCG and AFP) at baseline
      and then at various times after surgery to identify pathologic stage II disease. The timing
      of these studies depends on the stage of disease and/or type of disease management.

      Patients who undergo RPLND, have stage I or II disease, and do not receive adjuvant therapy
      (radiation or chemotherapy) are followed monthly during year 1, every 2 months during year 2,
      every 6 months during years 3-5, and annually thereafter.

      Patients who undergo RPLND, have stage II disease, and receive adjuvant therapy are followed
      every 2 months during year 1, every 4 months during year 2, every 6 months during years 3-5,
      and annually thereafter.

      Patients who do not undergo RPLND are followed monthly during year 1, every other month
      during year 2, every 6 months during years 3-5, and annually thereafter.

      PROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years.
    

Intervention name(s): immunohistochemistry staining method; laboratory biomarker analysis; radionuclide imaging
Intervention type(s): Other; Other; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stage I malignant testicular germ cell tumor; stage II malignant testicular germ cell tumor; testicular embryonal carcinoma; testicular choriocarcinoma; testicular teratoma; testicular yolk sac tumor; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and yolk sac tumor; testicular yolk sac tumor and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma