Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-27 @ 12:15 AM
Study NCT ID:
NCT02814032
Status:
UNKNOWN
Last Update Posted:
2023-07-20
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteomics of Papillary Thyroid Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}], 'ancestors': [{'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'differences in protein expression', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['proteomic', 'cervical lymph node metastasis'], 'conditions': ['Papillary Thyroid Carcinoma']}, 'referencesModule': {'references': [{'pmid': '17673125', 'type': 'BACKGROUND', 'citation': 'Gharib H, Papini E. Thyroid nodules: clinical importance, assessment, and treatment. Endocrinol Metab Clin North Am. 2007 Sep;36(3):707-35, vi. doi: 10.1016/j.ecl.2007.04.009.'}, {'pmid': '26462967', 'type': 'BACKGROUND', 'citation': 'Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.'}, {'pmid': '16788983', 'type': 'BACKGROUND', 'citation': 'Brown LM, Helmke SM, Hunsucker SW, Netea-Maier RT, Chiang SA, Heinz DE, Shroyer KR, Duncan MW, Haugen BR. Quantitative and qualitative differences in protein expression between papillary thyroid carcinoma and normal thyroid tissue. Mol Carcinog. 2006 Aug;45(8):613-26. doi: 10.1002/mc.20193.'}, {'pmid': '22275472', 'type': 'BACKGROUND', 'citation': 'Sofiadis A, Becker S, Hellman U, Hultin-Rosenberg L, Dinets A, Hulchiy M, Zedenius J, Wallin G, Foukakis T, Hoog A, Auer G, Lehtio J, Larsson C. Proteomic profiling of follicular and papillary thyroid tumors. Eur J Endocrinol. 2012 Apr;166(4):657-67. doi: 10.1530/EJE-11-0856. Epub 2012 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become the malignant neoplasm of fastest growing incidence rate. More than 85% thyroid carcinoma is papillary thyroid carcinoma. Cervical lymph node metastasis is common in papillary thyroid carcinoma patients. This study aim to reveal protein expression differences between papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis.', 'detailedDescription': '1. Object: Patients aged 18-65 years; newly diagnosed papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer.\n2. Clinical information, examination data: Information is obtained from medical record abstraction.\n3. Samples: Fresh frozen thyroid tissues from each sample group(normal histology, benign disease, papillary thyroid carcinoma with cervical lymph node metastasis, papillary thyroid carcinoma without cervical lymph node metastasis ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18-65 years; newly diagnosed papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed papillary thyroid carcinoma.\n* Undergo thyroidectomy according to the China thyroid association guidelines forthe Management of thyroid nodule and thyroid cancer.\n\nExclusion Criteria:\n\n* Current substance abuse/dependence.\n* Daily tobacco and alcohol use.\n* Whole neck irradiation or surgery.\n* Prior cancer diagnosis or chemotherapy treatment.\n* Active autoimmune disorder.\n* Uncontrolled allergic condition or asthma.\n* Chronic use of oral steroid medication.\n* Hormone therapy (estrogen, progestin compounds).'}, 'identificationModule': {'nctId': 'NCT02814032', 'briefTitle': 'Proteomics of Papillary Thyroid Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Inner Mongolia Medical University'}, 'officialTitle': 'Differences Protein Expression in Papillary Thyroid Carcinoma', 'orgStudyIdInfo': {'id': 'AHInnerMongolia-Thyroid-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PTC group 1', 'description': 'papillary thyroid carcinoma patients with cervical lymph node metastasis'}, {'label': 'PTC group 2', 'description': 'papillary thyroid carcinoma patients without cervical lymph node metastasis'}, {'label': 'Positive control group', 'description': 'benign disease'}, {'label': 'Negative control group', 'description': 'histologically normal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '010050', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shan Jin, PhD', 'role': 'CONTACT', 'email': 'jinshangood@163.com', 'phone': '+86-15849338280'}, {'name': 'Yun-Tian Yang, PhD', 'role': 'CONTACT', 'email': 'yangyuntian@sina.com', 'phone': '+86-15849338737'}], 'facility': 'Shan Jin', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}], 'centralContacts': [{'name': 'Shan Jin, PhD', 'role': 'CONTACT', 'email': 'jinshangood@163.com', 'phone': '+86-15849338280'}, {'name': 'Yun-tian Yang, PhD', 'role': 'CONTACT', 'email': 'yangyuntian@sina.com', 'phone': '+86-15849338737'}], 'overallOfficials': [{'name': 'Shan Jin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Inner Mongolia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}