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Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor (NCT00003800)

National Cancer Institute (NCI)
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.
  • Other: immunohistochemistry staining method
    • Other: laboratory biomarker analysis
      • Procedure: radionuclide imaging
        Ages eligible for Study
        15 Years and older
        Genders eligible for Study
        Male
        Accepts Healthy Volunteers
        No
        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.

        12 locations

        United States (12)
        • Veterans Affairs Medical Center - Lakeside Chicago
          Chicago, Illinois, United States, 60611-4494
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
          Chicago, Illinois, United States, 60611
        • Indiana University Cancer Center
          Indianapolis, Indiana, United States, 46202-5289
        • CCOP - Cedar Rapids Oncology Project
          Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Kalamazoo
          Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
          Kalamazoo, Michigan, United States, 49007
        • CCOP - Southern Nevada Cancer Research Foundation
          Las Vegas, Nevada, United States, 89106
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
          Cleveland, Ohio, United States, 44109
        • CCOP - Columbus
          Columbus, Ohio, United States, 43206
        • Fox Chase Cancer Center
          Philadelphia, Pennsylvania, United States, 19111-2497
        • CCOP - Scott and White Hospital
          Temple, Texas, United States, 76508
        • University of Wisconsin Comprehensive Cancer Center
          Madison, Wisconsin, United States, 53792-0001
        Status:
        unknown
        Type:
        Interventional
        Phase:
        -
        Start:
        30 April, 1999
        Updated:
        29 November, 2012
        Participants:
        76
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