Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT06241092
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymph node metastasis', 'timeFrame': '2021.10.1', 'description': 'Lymph node metastasis is frequently influenced by a myriad of factors, and tumor heterogeneity stands out as a significant contributing element.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '2021.10.1', 'description': 'Disease-free survival is defined as the time from randomization to the first occurrence of a relapse, progression, or death from any cause, commonly used in clinical trials of adjuvant therapy after curative surgery or radiation therapy. It is also used as a primary endpoint in studies of neoadjuvant therapy and a useful endpoint for evaluating the efficacy of treatments that aim to prevent cancer recurrence research'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Papillary Thyroid Carcinoma; Molecular Heterogeneity; Multi-model Analysis; Artificial Intelligence; Lymph Node Metastases; Disease-free Survival']}, 'descriptionModule': {'briefSummary': 'This study involved a comprehensive analysis of 256 PTC patients from Sun Yat-sen Memorial Hospital of Sun Yat-sen University (SYSMH) and 499 patients from The Cancer Genome Atlas. DNA-based next-generation sequencing (NGS) and single-cell RNA sequencing (scRNA-seq) were employed to capture genetic alterations and TME heterogeneity. A deep learning multimodal model was developed by incorporating matched histopathology slide images, genomic, transcriptomic, immune cells data to predict LNM and disease-free survival (DFS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n≥ 18 years of age Diagnosis of Papillary thyroid carcinoma at least one months before trial Willing to return for required follow-up (posttest) visits\n\nExclusion Criteria:\n\nThe patient requires valve or other likely surgery The patient is unable to carry out any physical activity without discomfort The patient had thyroid ache within three months prior to enrollment The patient refuses to give informed consent The patient is a candidate for coronary bypass surgery or something similar'}, 'identificationModule': {'nctId': 'NCT06241092', 'briefTitle': 'AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma: A Retrospective Study', 'orgStudyIdInfo': {'id': 'SYSEC-KY-KS-2021-259'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TCGA'}, {'label': 'SYSMH'}], 'interventions': [{'type': 'OTHER', 'armGroupLabels': ['SYSMH', 'TCGA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Herui Yao, PhD', 'role': 'CONTACT', 'email': 'yaoherui@mail.sysu.edu.cn', 'phone': '+8613500018020'}, {'name': 'Yufang Yu', 'role': 'CONTACT', 'email': 'yuyf9@mail.sysu.edu.cn', 'phone': '+8613660238987'}], 'facility': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Yunfang Yu', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}