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RATIONALE: Imaging procedures such as CT scans help the doctor in detecting cancer or the recurrence of cancer. Increasing the number of times a CT scan is given may improve the ability to detect stage I testicular cancer.
PURPOSE: Randomized clinical trial to determine if there is a different result from two different schedules of CT scans in treating patients with stage I testicular cancer after undergoing orchiectomy.
- Determine whether there is a difference between two schedules of CT scan surveillance in respect to stage of disease at relapse, survival, the investigation determining relapse, and incidence of second malignancies in patients with stage I testicular teratoma after orchidectomy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence of vascular invasion.
After orchidectomy, patients are randomized into two schedules (arms I and II) of CT scan follow up.
- Arm I: Patients repeat chest and abdominal CT scans no later than 3 months after orchidectomy and again at 12 months to confirm that the patient is clear of disease.
- Arm II: Patients repeat chest and abdominal CT scans at 3, 6, 9, 12, and 24 months after orchidectomy.
Patients are followed monthly for the first year after orchidectomy, then every 2 months for the second year, then every 3 months for the third year, and then every 4-6 months thereafter.
PROJECTED ACCRUAL: There will be 400-900 patients accrued into this study over 3-6 years.
Allocation: Randomized, Control: Active Control, Primary Purpose: Diagnostic
Testicular Germ Cell Tumor
Mount Vernon Hospital
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:41-0400
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Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.
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 patien...
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Can a systematic scoring procedure provide crucial information on the status of highly heterogeneous immature human testicular tissues in the context of cryopreservation for fertility preservation?
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An imaging technique using a device which combines TOMOGRAPHY, EMISSION-COMPUTED, SINGLE-PHOTON and TOMOGRAPHY, X-RAY COMPUTED in the same session.
Computed tomography where there is continuous X-ray exposure to the patient while being transported in a spiral or helical pattern through the beam of irradiation. This provides improved three-dimensional contrast and spatial resolution compared to conventional computed tomography, where data is obtained and computed from individual sequential exposures.
Computed tomography modalities which use a cone or pyramid-shaped beam of radiation.
An unusual and aggressive tumor of germ-cell origin that reproduces the extraembryonic structures of the early embryo. It is the most common malignant germ cell tumor found in children. It is characterized by a labyrinthine glandular pattern of flat epithelial cells and rounded papillary processes with a central capillary (Schiller-Duval body). The tumor is rarely bilateral. Before the use of combination chemotherapy, the tumor was almost invariably fatal. (From DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1189)
Tomography using x-ray transmission and a computer algorithm to reconstruct the image.
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