Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 9:11 PM
Study NCT ID:
NCT01371695
Status:
UNKNOWN
Last Update Posted:
2011-06-13
First Post:
2011-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'frozen serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-10', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IGF-II levels'], 'conditions': ['Cervical Cancer', 'Cervical Intraepithelial Neoplasia II', 'Cervical Intraepithelial Neoplasia III']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'university clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 75 years\n* Female\n* Normal medical history\n* Medical history of a single type of cancer confirmed by biopsy or equivalent criteria\n* Squamous cell carcinoma of organs other than cervix\n* Adenocarcinoma\n* Medical history of inflammatory disease\n* May be pregnant\n* Pap smear positive for Cervical Intraepithelial Neoplasia II or III\n* Squamous cell cervical cancer confirmed by biopsy\n* Informed consent\n* Willingness to submit a blood sample by venipuncture\n* Willingness to submit a second blood sample if necessary\n\nExclusion Criteria:\n\n* Age \\< 18 or \\> 75 years\n* Medical history of cancer other than cervical cancer, Non-islet-cell tumor hypoglycemia, Growth hormone deficiency, Acromegaly, Hepatoma, inflammatory disease in addition to confirmed CIN and cervical cancer'}, 'identificationModule': {'nctId': 'NCT01371695', 'briefTitle': 'Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Onconix, Inc'}, 'officialTitle': 'Phase 1 of Serum IGF II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer', 'orgStudyIdInfo': {'id': 'onc11-03-164'}}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Health Sciences', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onconix, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sharad A. Ghamande', 'oldOrganization': 'Georgia Health Sciences University'}}}}