Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00471120
Status:
TERMINATED
Last Update Posted:
2015-08-05
First Post:
2007-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Study terminated due to protocol deficiencies.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2007-05-07', 'studyFirstSubmitQcDate': '2007-05-07', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women.', 'timeFrame': 'Upon review of the assays.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Uterine Cancer', 'Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '15269006', 'type': 'BACKGROUND', 'citation': 'Wang Q, Wang L, Feng YH, Li X, Zeng R, Gorodeski GI. P2X7 receptor-mediated apoptosis of human cervical epithelial cells. Am J Physiol Cell Physiol. 2004 Nov;287(5):C1349-58. doi: 10.1152/ajpcell.00256.2004. Epub 2004 Jul 21.'}, {'pmid': '15459114', 'type': 'BACKGROUND', 'citation': 'Wang L, Feng YH, Gorodeski GI. Epidermal growth factor facilitates epinephrine inhibition of P2X7-receptor-mediated pore formation and apoptosis: a novel signaling network. Endocrinology. 2005 Jan;146(1):164-74. doi: 10.1210/en.2004-1026. Epub 2004 Sep 30.'}, {'pmid': '15728711', 'type': 'BACKGROUND', 'citation': 'Feng YH, Wang L, Wang Q, Li X, Zeng R, Gorodeski GI. ATP stimulates GRK-3 phosphorylation and beta-arrestin-2-dependent internalization of P2X7 receptor. Am J Physiol Cell Physiol. 2005 Jun;288(6):C1342-56. doi: 10.1152/ajpcell.00315.2004. Epub 2005 Feb 23.'}, {'pmid': '16624800', 'type': 'BACKGROUND', 'citation': 'Feng YH, Li X, Wang L, Zhou L, Gorodeski GI. A truncated P2X7 receptor variant (P2X7-j) endogenously expressed in cervical cancer cells antagonizes the full-length P2X7 receptor through hetero-oligomerization. J Biol Chem. 2006 Jun 23;281(25):17228-17237. doi: 10.1074/jbc.M602999200. Epub 2006 Apr 18.'}, {'pmid': '17035398', 'type': 'BACKGROUND', 'citation': 'Li X, Zhou L, Feng YH, Abdul-Karim FW, Gorodeski GI. The P2X7 receptor: a novel biomarker of uterine epithelial cancers. Cancer Epidemiol Biomarkers Prev. 2006 Oct;15(10):1906-13. doi: 10.1158/1055-9965.EPI-06-0407.'}]}, 'descriptionModule': {'briefSummary': 'This study aims at developing an accurate, simple, and cost-effective method for screening and early detection of uterine cancers', 'detailedDescription': 'The present study aims at developing an accurate, simple and cost-effective method for screening and early detection of uterine cancers in women using novel inventions and biotechnology methods for collection and assay of uterine cells. Results of P2X7 assays using tissues obtained from women with known uterine cancer and from women with histologically normal endometrium will be compared. These data will also serve as basis for future studies to test the predictive value of the method in population-based studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women scheduled to undergo hysterectomy\n* ages 18 years and older\n\nExclusion Criteria:\n\n* pregnant women\n* students or employees under the direct supervision on the investigators.'}, 'identificationModule': {'nctId': 'NCT00471120', 'briefTitle': 'Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytoCore, Inc.'}, 'officialTitle': 'Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women', 'orgStudyIdInfo': {'id': '13806-CC113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'P2x7 Assay', 'description': 'Compare assay results with biopsy', 'interventionNames': ['Other: P2x7 assay']}], 'interventions': [{'name': 'P2x7 assay', 'type': 'OTHER', 'description': 'compare P2X7 assay to biopsy', 'armGroupLabels': ['P2x7 Assay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205-7199', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital CASE Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75390-9032', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555-0156', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Jay Pinkerton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dick Domanik', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Scientist', 'investigatorFullName': 'Dick Domanik', 'investigatorAffiliation': 'CytoCore, Inc.'}}}}