Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-01-25 @ 4:28 AM
Study NCT ID:
NCT06539702
Status:
RECRUITING
Last Update Posted:
2024-08-06
First Post:
2024-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-01', 'releaseDate': '2024-08-19'}], 'estimatedResultsFirstSubmitDate': '2024-08-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Pathological specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Platelet Volume (MPV) (fL)', 'timeFrame': '1 week', 'description': 'Mean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients.'}, {'measure': 'Neutrophil/lenfosit Ratio (NLR)(103/µL)', 'timeFrame': '1 week', 'description': 'Neutrophil/lymphocyte ratio (NLR) will be calculated by taking the Neutrophil (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients.'}, {'measure': 'Platelet/Lenfosit Ratio (PLR)(103/µL)', 'timeFrame': '1 week', 'description': 'Platelet/lymphocyte ratio (PLR) will be calculated by taking the Platelet (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients.'}, {'measure': 'Lenfosit/Monosit Ratio (LMR)(103/µL)', 'timeFrame': '1 week', 'description': 'Lymphocyte/Monocyte Ratio (LMR) will be calculated by taking the Lymphocyte (103/µL) and Monocyte (103/µL) values in the preoperative hemogram parameters of all patients.'}], 'secondaryOutcomes': [{'measure': 'BRAF molecular test', 'timeFrame': '1 week', 'description': 'Pathological molecular test (25 patients)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid', 'carcinoma', 'Bethesda 3', 'BRAF'], 'conditions': ['Blood Platelet Disorder', 'BRAF V600E', 'Thyroid Nodule', 'Cytologic Atypia']}, 'referencesModule': {'references': [{'pmid': '35006341', 'type': 'RESULT', 'citation': 'Bostan H, Sencar ME, Calapkulu M, Hepsen S, Akhanli P, Duger H, Ucan B, Kizilgul M, Ozturk Unsal I, Ozbek M, Cakal E. The predictive value of hematologic parameters in the risk of thyroid malignancy in cases with atypia/follicular lesion of undetermined significance. Eur Arch Otorhinolaryngol. 2022 Aug;279(8):4077-4084. doi: 10.1007/s00405-021-07248-9. Epub 2022 Jan 10.'}, {'pmid': '33908335', 'type': 'RESULT', 'citation': "Acar S, Ercetin C, Sahbaz NA, Tutal F, Yapalak Y, Cosan F, Erbil Y. Hemodynamic Instability during Thyroidectomy in Graves' Disease. J Invest Surg. 2022 Mar;35(3):627-631. doi: 10.1080/08941939.2021.1914785. Epub 2021 Apr 28."}]}, 'descriptionModule': {'briefSummary': 'The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology.\n\nThe secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology.\n\nPrimary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity.', 'detailedDescription': 'The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology.\n\nThe secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology.\n\nPrimary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity. This study aims to reduce unnecessary thyroidectomies, thyroidectomy complications and treatment costs due to Bethesda 3 cytology.\n\nThe age and gender of all patients to be included in the study will be recorded. Mean Platelet Volume (MPV), Neutrophil/lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR) and Lymphocyte/Monocyte Ratio (LMR) will be recorded in preoperative hemograms. Nodule sizes detected by preoperative Bethesda III cytology will be recorded. The sizes of nodules with preoperative AUS cytology after thyroidectomy, determined as a result of pathological examination, will be recorded. Patients with malignant cytology will be divided into papillary thyroid carcinoma (PTC), Follicular Thyroid Carcinoma (FTC), and tumor sizes will be recorded. Among the patients included in the study, BRAF molecular testing will be performed on the preoperative cytology of 25 patients whose thyroidectomy materials were reported to be malignant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18 -75', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between the ages of 18 -75\n2. Patients who were diagnosed with Bethesda III as a result of preoperative FNAC and decided to undergo thyroidectomy\n\nExclusion Criteria:\n\n1. Patients over 18 years old and under 75 years old\n2. Patients with malignancy detected in another focus with preoperative Bethesda III FNAC\n3. Detection of malignancy in another focus other than the nodule with Bethesda III cytological result after thyroidectomy\n4. Failure to obtain preoperative hemogram results Patients who do not agree to participate in scientific studies for BRAF testing'}, 'identificationModule': {'nctId': 'NCT06539702', 'acronym': 'Bethesda3', 'briefTitle': 'Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'To Reveal the Predictive Value of Preoperative Hemogram Parameters and BRAF Molecular Test in Predicting Malignancy in Cases With Thyroid Nodules Detected by Bethesda 3 Cytology.', 'orgStudyIdInfo': {'id': 'E-48670771-514.99-237222286'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2/Group B (Benign), Group M (Malign)', 'description': 'Mean Platelet Volume (MPV), Neutrophil/lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR) and Lymphocyte/Monocyte Ratio (LMR) will be recorded in preoperative hemograms. Among the patients included in the study, BRAF molecular testing will be performed on the preoperative cytology of 25 patients whose thyroidectomy materials were reported to be malignant. with thyroid nodule identified by Bethesda 3 cytology were examined retrospectively. According to the pathology results, they were divided into 2 groups: benign and malignant.\n\nGroup B (Benign);Preoperative hemogram parameters, Bethesda 3 cytology, Thyroidectomy, benign pathology.\n\nGroup M (Malign);Preoperative hemogram parameters, Betheda 3 cytology, Thyroidectomy, malign pathology, BRAF molecular test'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ugur Kesici, Assoc. Prof', 'role': 'CONTACT', 'email': 'ugurkesici77@mynet.com', 'phone': '05445474710'}, {'role': 'CONTACT', 'email': 'ugurkesici77@mynet.com', 'phoneExt': 'Kesici'}, {'name': 'Ugur Kesici', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prof. Dr. Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ugur 1 Kesici, Assoc. Prof.', 'role': 'CONTACT', 'email': 'ugur.kesici@sbu.edu.tr', 'phone': '00905445474710', 'phoneExt': '50124'}, {'name': 'Ugur 1 Kesici, Assoc. Prof.', 'role': 'CONTACT', 'email': 'ugurkesici77@mynet.com', 'phone': '00905445474710', 'phoneExt': '50124'}], 'overallOfficials': [{'name': 'Ugur Kesici, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-19', 'type': 'RELEASE'}, {'date': '2024-11-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Saglik Bilimleri Universitesi'}}}}