Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT00406120
Status:
WITHDRAWN
Last Update Posted:
2018-06-26
First Post:
2006-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Molecular Prognostic Test for Eye Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D002830', 'term': 'Choroid Neoplasms'}, {'id': 'D015811', 'term': 'Iris Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}], 'ancestors': [{'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'It has come to our attention that the site was not necessary for our research project.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-21', 'studyFirstSubmitDate': '2006-11-29', 'studyFirstSubmitQcDate': '2006-11-29', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presentation of Primary Tumor to Metastasis', 'timeFrame': '60 months'}]}, 'conditionsModule': {'keywords': ['eye', 'uvea', 'iris', 'choroid', 'ciliary body', 'melanoma', 'iris melanoma', 'choroidal melanoma', 'ciliary body melanoma', 'uveal melanoma', 'posterior uveal melanoma', 'prognosis', 'metastasis', 'genetic testing', 'molecular testing', 'gene expression profiling'], 'conditions': ['Uveal Neoplasms', 'Choroid Neoplasms', 'Iris Neoplasms']}, 'referencesModule': {'references': [{'pmid': '17065425', 'type': 'BACKGROUND', 'citation': 'Onken MD, Worley LA, Davila RM, Char DH, Harbour JW. Prognostic testing in uveal melanoma by transcriptomic profiling of fine needle biopsy specimens. J Mol Diagn. 2006 Nov;8(5):567-73. doi: 10.2353/jmoldx.2006.060077.'}, {'pmid': '16651410', 'type': 'BACKGROUND', 'citation': 'Onken MD, Ehlers JP, Worley LA, Makita J, Yokota Y, Harbour JW. Functional gene expression analysis uncovers phenotypic switch in aggressive uveal melanomas. Cancer Res. 2006 May 1;66(9):4602-9. doi: 10.1158/0008-5472.CAN-05-4196.'}, {'pmid': '16226537', 'type': 'BACKGROUND', 'citation': 'Onken MD, Lin AY, Worley LA, Folberg R, Harbour JW. Association between microarray gene expression signature and extravascular matrix patterns in primary uveal melanomas. Am J Ophthalmol. 2005 Oct;140(4):748-9. doi: 10.1016/j.ajo.2005.04.024.'}, {'pmid': '15966293', 'type': 'BACKGROUND', 'citation': 'Faulkner-Jones BE, Foster WJ, Harbour JW, Smith ME, Davila RM. Fine needle aspiration biopsy with adjunct immunohistochemistry in intraocular tumor management. Acta Cytol. 2005 May-Jun;49(3):297-308. doi: 10.1159/000326153.'}, {'pmid': '15492234', 'type': 'BACKGROUND', 'citation': 'Onken MD, Worley LA, Ehlers JP, Harbour JW. Gene expression profiling in uveal melanoma reveals two molecular classes and predicts metastatic death. Cancer Res. 2004 Oct 15;64(20):7205-9. doi: 10.1158/0008-5472.CAN-04-1750.'}]}, 'descriptionModule': {'briefSummary': 'Up to half of patients with ocular melanoma (also called iris, choroidal or uveal melanoma) develop metastasis. We have found that certain molecular features of the eye tumor can be detected by gene expression profiling and accurately predict which patients will develop metastasis. This molecular test could eventually allow high risk patients to receive preventative therapy to delay or prevent the development of metastasis. The goal of this study is to prospectively validate the predictive accuracy of the gene expression-based molecular test and compare it to monosomy 3, the most common but potentially less accurate molecular marker for metastasis in ocular melanoma.', 'detailedDescription': 'We have discovered a gene expression profile derived from primary uveal melanomas that accurately predicts which patients will develop metastasis. Tumors with a class 1 gene expression signature have a very low risk, and those with a class 2 signature have a high risk of metastasis. The molecular test was initially performed on tissue obtained from enucleated eyes using commercial microarray platforms. We are now able to perform the molecular test on fine needle biopsy specimens, and we have developed a customized test that has greater dynamic range and sensitivity than commercial microarray platforms. The goal of this study is to validate the prognostic accuracy of the customized platform by performing the molecular test on primary uveal melanomas obtained from enucleation, local tumor resection or fine needle biopsy. Each sample will be diagnosed as either class 1, class 2 or indeterminate. Outcomes will be collected and the ability of the molecular diagnosis to predict metastasis will be evaluated at regular intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients have uveal melanoma and are being treated wither by enucleation or plaque radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of melanoma of the iris, ciliary body and/or choroid\n* treatment to include enucleation, radiotherapy or local tumor resection\n\nExclusion Criteria:\n\n* evidence of marked tumor necrosis'}, 'identificationModule': {'nctId': 'NCT00406120', 'briefTitle': 'Validation of a Molecular Prognostic Test for Eye Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma', 'orgStudyIdInfo': {'id': '98-0042-A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fine needle aspiration biopsy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'J. William Harbour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}