Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 10:31 AM
Study NCT ID:
NCT07074535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT and Endoscopic Biopsy Image-Based Deep Learning for Predicting Left Recurrent Laryngeal Nerve Lymph Node Metastasis in Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D014826', 'term': 'Vocal Cord Paralysis'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUROC (Area Under the Receiver Operating Characteristic Curve)', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'The discriminant ability of the comprehensive evaluation model at different thresholds (positive vs. negative)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Cancer (SCC)', 'Recurrent Laryngeal Nerve Palsy', 'Deep Learning', 'Postoperative Complication']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to develop a predictive model for left recurrent laryngeal nerve (RLN) lymph node metastasis using deep learning algorithms. The model will be developed using clinical data from previous esophageal cancer surgeries, including preoperative CT imaging, and histopathological images from gastroscopic biopsies. The model will also be validated through prospective clinical trials to guide the intraoperative lymph node dissection, thereby reducing postoperative risks of RLN injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included were all esophageal cancer patients who received surgery and standard lymph node dissection in our hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Preoperative gastroscopic biopsy confirmed esophageal squamous cell carcinoma；\n* The patient underwent esophagectomy with lymph nodes dissection along the left recurrent laryngeal nerve.\n\nExclusion Criteria:\n\n* The patient's medical records are incomplete；\n* The patient refused to participate in the trial."}, 'identificationModule': {'nctId': 'NCT07074535', 'briefTitle': 'CT and Endoscopic Biopsy Image-Based Deep Learning for Predicting Left Recurrent Laryngeal Nerve Lymph Node Metastasis in Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'CT and Endoscopic Biopsy Image-Based Deep Learning for Predicting Left Recurrent Laryngeal Nerve Lymph Node Metastasis in Esophageal Cancer', 'orgStudyIdInfo': {'id': 'CEDREL-LNM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Left RLN lymph node （+）', 'description': 'Postoperative pathological results confirmed the metastasis of left recurrent laryngeal nerve lymph nodes.'}, {'label': 'Left RLN lymph node （-）', 'description': 'Postoperative pathological results confirmed the negative of left recurrent laryngeal nerve lymph nodes.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'country': 'China', 'facility': 'Daping Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Datasets and codes for the study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}