Diagnostic Study of Patients With Stage I Testicular Cancer
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.
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.
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Testicular Germ Cell Tumor
Intervention
immunohistochemistry staining method, laboratory biomarker analysis, radionuclide imaging
Location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago
Illinois
United States
60611
Status
Active, not recruiting
Source
Eastern Cooperative Oncology Group
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00003800
- Information obtained from ClinicalTrials.gov on December 27, 2012
Medical and Biotech [MESH] Definitions
Molecular Imaging
The use of molecularly targeted imaging probes to localize and/or monitor biochemical and cellular processes via various imaging modalities that include RADIONUCLIDE IMAGING; ULTRASONOGRAPHY; MAGNETIC RESONANCE IMAGING; fluorescence imaging; and MICROSCOPY.
Technetium Tc 99m Pentetate
A technetium imaging agent used in renal scintigraphy, computed tomography, lung ventilation imaging, gastrointestinal scintigraphy, and many other procedures which employ radionuclide imaging agents.
Cardiac Imaging Techniques
Visualization of the heart structure and cardiac blood flow for diagnostic evaluation or to guide cardiac procedures via techniques including ENDOSCOPY (cardiac endoscopy, sometimes refered to as cardioscopy), RADIONUCLIDE IMAGING; MAGNETIC RESONANCE IMAGING; TOMOGRAPHY; or ULTRASONOGRAPHY.
Gated Blood-pool Imaging
Radionuclide ventriculography where scintigraphic data is acquired during repeated cardiac cycles at specific times in the cycle, using an electrocardiographic synchronizer or gating device. Analysis of right ventricular function is difficult with this technique; that is best evaluated by first-pass ventriculography (VENTRICULOGRAPHY, FIRST-PASS).
Technetium Tc 99m Exametazime
A gamma-emitting radionuclide imaging agent used in the evaluation of regional cerebral blood flow and in non-invasive dynamic biodistribution studies and myocardial imaging. It has also been used to label leukocytes in the investigation of inflammatory bowel diseases.
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