Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-01 @ 5:20 AM
Study NCT ID:
NCT00003800
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Study of Patients With Stage I Testicular Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563236', 'term': 'Testicular Germ Cell Tumor'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'C562472', 'term': 'Teratoma, Testicular'}, {'id': 'D018240', 'term': 'Endodermal Sinus Tumor'}, {'id': 'D013724', 'term': 'Teratoma'}, {'id': 'D018236', 'term': 'Carcinoma, Embryonal'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D008649', 'term': 'Mesonephroma'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of regional or metastatic spread', 'timeFrame': 'observed at least annually', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I malignant testicular germ cell tumor', 'stage II malignant testicular germ cell tumor', 'testicular embryonal carcinoma', 'testicular choriocarcinoma', 'testicular teratoma', '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'], 'conditions': ['Testicular Germ Cell Tumor']}, 'descriptionModule': {'briefSummary': "RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer.\n\nPURPOSE: 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.", 'detailedDescription': "OBJECTIVES:\n\n* 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.\n* Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients.\n\nOUTLINE: 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.\n\nAll 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.\n\nPatients 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.\n\nPatients 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.\n\nPatients 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.\n\nPROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Clinical stage I nonseminomatous germ cell tumor of the testis\n* Must have had a radical inguinal orchiectomy with or without retroperitoneal lymph node dissection within prior 12 weeks\n\n * AFP and HCG normal or decreasing after orchiectomy at a rate consistent with known half lives\n * Pathology blocks and radiologic studies available\n* No metastatic disease on physical exam or chest or abdominal/pelvic CT\n* No pure seminoma (unless associated with elevated AFP at diagnosis)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 15 and over\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No prior malignancy including prior primary testicular cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00003800', 'briefTitle': 'Diagnostic Study of Patients With Stage I Testicular Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor', 'orgStudyIdInfo': {'id': 'CDR0000066944'}, 'secondaryIdInfos': [{'id': 'U10CA021115', 'link': 'https://reporter.nih.gov/quickSearch/U10CA021115', 'type': 'NIH'}, {'id': 'ECOG-8897'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Laboratory/CT evaluation', 'description': 'Observation following orchiectomy', 'interventionNames': ['Other: immunohistochemistry staining method', 'Other: laboratory biomarker analysis', 'Procedure: radionuclide imaging']}], 'interventions': [{'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'armGroupLabels': ['Laboratory/CT evaluation']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['Laboratory/CT evaluation']}, {'name': 'radionuclide imaging', 'type': 'PROCEDURE', 'armGroupLabels': ['Laboratory/CT evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-4494', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Lakeside Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52403-1206', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Cedar Rapids Oncology Project', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '49007-3731', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Kalamazoo', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'CCOP - Southern Nevada Cancer Research Foundation', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "MetroHealth's Cancer Care Center at MetroHealth Medical Center", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43206', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19111-2497', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'CCOP - Scott and White Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '53792-0001', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Richard S. Foster, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Indiana University Melvin and Bren Simon Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}