Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT06399159
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], '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'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}, {'id': 'D008197', 'term': 'Lymph Node Excision'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of lymph node metastasis', 'timeFrame': 'October 2024', 'description': 'All surgical specimens were subjected to paraffin-embedded histopathological examination，depending on the pathological findings, it is classified as the presence or absence of lymph node metastases.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound', 'deep learning', 'cytology'], 'conditions': ['Papillary Thyroid Carcinoma', 'Lymph Node Metastasis']}, 'descriptionModule': {'briefSummary': "Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. A new study's multimodal model fuses preoperative US and cytology images to better predict lymph node metastasis, aiming to improve treatment plans, reduce unnecessary surgeries, and enhance patient outcomes.", 'detailedDescription': 'Thyroid carcinoma incidence has been on the rise in recent years. Papillary thyroid carcinoma is the most prevalent type of differentiated thyroid carcinoma, accounting for 85% to 90% of malignant thyroid tumors. Despite its indolent nature, cervical lymph node metastasis is frequently observed at an early stage. Papillary thyroid carcinoma patients with cervical lymph node metastasis face an elevated risk of recurrence, distant metastasis, and mortality. Thus, non-invasive preoperative prediction of cervical lymph node metastasis is particularly vital for guiding treatment plans and prognostic. this study has developed a multimodal model integrating preoperative US images with cytological images of papillary thyroid carcinoma patients. The aim is to enhance the predictive accuracy for cervical lymph node metastasis, reduce unnecessary lymph node dissections, and provide real-time, precise guidance for determining the extent of surgical resection and prognostic assessment. This approach aims to optimize patient treatment strategies and enhance therapeutic outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with papillary thyroid cancer from ten hospitals in China', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Underwent thyroidectomy and bilateral lymph node dissection with pathological confirmation of PTC\n* Completed US examination within one week before surgery\n* Underwent preoperative us-guided FNAC\n* Completed cytological images at 400× magnification under a microscope\n\nExclusion Criteria:\n\n* Patients who underwent only unilateral thyroidectomy\n* Patients with cervical lymph nodes shown on preoperative ultrasound'}, 'identificationModule': {'nctId': 'NCT06399159', 'briefTitle': 'Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nanchong Central Hospital'}, 'officialTitle': 'An Interpretable Multimodal Model Based on Cytology Ultrasound Noninvasively Predicts Lymph Node Metastasis in cN0 Papillary Thyroid Cancer', 'orgStudyIdInfo': {'id': 'Review-2023-109'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort with Lymph Node Metastasis', 'description': 'Depending on the pathological findings, it is classified as the presence of lymph node metastases.', 'interventionNames': ['Procedure: Thyroidectomy and lymph node dissection']}, {'label': 'Cohort without Lymph Node Metastasis', 'description': 'Depending on the pathological findings, it is classified as the absence of lymph node metastases.', 'interventionNames': ['Procedure: Thyroidectomy and lymph node dissection']}], 'interventions': [{'name': 'Thyroidectomy and lymph node dissection', 'type': 'PROCEDURE', 'description': 'All surgical specimens of thyroidectomy and lymph node dissection were subjected to paraffin-embedded histopathological examination, and postoperative were categorized as with cervical lymph node metastasis and without cervical lymph node metastasis.', 'armGroupLabels': ['Cohort with Lymph Node Metastasis', 'Cohort without Lymph Node Metastasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '637000', 'city': 'Nanchong', 'state': 'Sichuan', 'country': 'China', 'facility': 'Nanchong central hospital', 'geoPoint': {'lat': 30.79508, 'lon': 106.08473}}], 'overallOfficials': [{'name': 'Xiachuan Qin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanchong Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanchong Central Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiachuan Qin,MD', 'investigatorAffiliation': 'Nanchong Central Hospital'}}}}