Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor
immunohistochemistry staining method
+ laboratory biomarker analysis
+ radionuclide imaging
Maladies génito-urinaires+16
+ Maladies Génitales
+ Maladies du système endocrinien
Étude diagnostique
Résumé
Date de début de l'étude : 16 novembre 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.76 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Diagnostic
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Homme
Le sexe biologique des participants éligibles à s'inscrire.De 15 à 120 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Pas d'interventionObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 12 sites
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, United StatesOuvrir Veterans Affairs Medical Center - Lakeside Chicago dans Google MapsRobert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesIndiana University Cancer Center
Indianapolis, United StatesCCOP - Cedar Rapids Oncology Project
Cedar Rapids, United States