Diagnostic Study of Patients With Stage I Testicular Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor

Conditions
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Testicular Germ Cell Tumor

Intervention / Treatment
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* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Procedure: radionuclide imaging


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Clinical stage I nonseminomatous germ cell tumor of the testis Must have had a radical inguinal orchiectomy with or without retroperitoneal lymph node dissection within prior 12 weeks AFP and HCG normal or decreasing after orchiectomy at a rate consistent with known half lives Pathology blocks and radiologic studies available No metastatic disease on physical exam or chest or abdominal/pelvic CT No pure seminoma (unless associated with elevated AFP at diagnosis) PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior malignancy including prior primary testicular cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Laboratory/CT evaluation<br>Observation following orchiectomy | Other: immunohistochemistry staining method<br> <br> Other: laboratory biomarker analysis<br> <br> Procedure: radionuclide imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of regional or metastatic spread | Patients with putative stage A non-seminomatous germ cell tumors are assessed at baseline using chest xray and blood markers. They are then followed monthly during year 1, every 2 months during year 2, twice a year during years 3-5, and annually thereafter. | observed at least annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testicular teratoma, stage I malignant testicular germ cell tumor, stage II malignant testicular germ cell tumor, testicular embryonal carcinoma, testicular choriocarcinoma, 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