Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-08 @ 4:04 AM
Study NCT ID:
NCT01954134
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2013-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
P53 in Differentiated Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-26', 'studyFirstSubmitDate': '2013-09-11', 'studyFirstSubmitQcDate': '2013-09-26', 'lastUpdatePostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'There was not any risk for patients.', 'timeFrame': 'with in the first 8-10 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tumor Suppressor Protein p53,', 'Iodine Radioisotopes'], 'conditions': ['Thyroid Neoplasms']}, 'referencesModule': {'references': [{'pmid': '19693693', 'type': 'RESULT', 'citation': 'Wu M, Mao C, Chen Q, Cu XW, Zhang WS. Serum p53 protein and anti-p53 antibodies are associated with increased cancer risk: a case-control study of 569 patients and 879 healthy controls. Mol Biol Rep. 2010 Jan;37(1):339-43. doi: 10.1007/s11033-009-9744-7. Epub 2009 Aug 20.'}, {'pmid': '16964393', 'type': 'RESULT', 'citation': 'Muller M, Meyer M, Schilling T, Ulsperger E, Lehnert T, Zentgraf H, Stremmel W, Volkmann M, Galle PR. Testing for anti-p53 antibodies increases the diagnostic sensitivity of conventional tumor markers. Int J Oncol. 2006 Oct;29(4):973-80.'}, {'pmid': '24234516', 'type': 'DERIVED', 'citation': 'Hasbek Z, Turgut B, Erselcan T. p53 antibody: is it an indicator of dedifferentiated thyroid cancer? Ann Nucl Med. 2014 Jan;28(1):42-6. doi: 10.1007/s12149-013-0783-8.'}]}, 'descriptionModule': {'briefSummary': 'In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is considered as radioiodine resistant or in another words in the process of dedifferentiation. The aim of the present study was to search a simple blood test that could lead to early identification of patients with dedifferentiation. In this respect, we investigate whether the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients with high levels of thyroglobulin (tg) and negative I-131 scan.', 'detailedDescription': 'In the present study enrolled were 171 patients with mean age of 47.7±13.5 yrs (range; 16-80yrs) and 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs). 134 (78.4%) patients were female and 37 (21.6%) patients were male.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 171 patients with an age range of 16-80 yrs (mean: 47.7±13.5 yrs) and a total of 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs) were included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were diagnosed with DTC\n* Treated with total and/or near-total thyroidectomy\n* Referred for I-131 ablation therapy or low dose I-131 whole body scan (WBS)\n* Between December 2010 and January 2013.\n\nExclusion Criteria:\n\n* Dose 131-I given in another hospital\n* Radioiodine treatment more than one year after thyroidectomy.'}, 'identificationModule': {'nctId': 'NCT01954134', 'briefTitle': 'P53 in Differentiated Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'P53 Antibody; Is it an Indicator of Dedifferentiated Thyroid Cancer?', 'orgStudyIdInfo': {'id': 'T-485'}, 'secondaryIdInfos': [{'id': 'T-485', 'type': 'OTHER', 'domain': 'Cumhuriyet University Scientific Research Project Unit'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'thyroid cancer, healty', 'description': 'Thyroid cancer group: patients with differentiated or dedifferentiated thyroid cancer Healty: control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'country': 'Turkey (Türkiye)', 'facility': 'Cumhuriyet University, School of Medicine, Dept. of Nuclear Medicine', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'overallOfficials': [{'name': 'Zekiye Hasbek, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cumhuriyet University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cumhuriyet University, School of Medicine, Department of Nuclear Medicine', 'investigatorFullName': 'Zekiye HASBEK, M.D., Assistant Professor', 'investigatorAffiliation': 'Cumhuriyet University'}}}}