Radiomics for Preoperative Jaw Cyst Differentiation

StatusUnknown
PhaseNot specified
Started

Record status This record was last updated September 19, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Sep 1, 2024 to Sep 5, 2024
    • Eligibility criteria shortened, about 9 words
    • Study description expanded, about 6 words
    • Site details revised
    • Study title shortened, about 4 words
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study focuses on jawbone cystic lesions, including odontogenic tumors like ameloblastoma and various cysts. Treatment approaches differ; ameloblastomas often require surgical excision due to potential recurrence and metastasis, while cystic lesions may be treated with curettage and marsupialization. Accurate preoperative diagnosis is crucial for optimal treatment outcomes, as inappropriate choices can lead to delayed treatment or overtreatment, affecting patient quality of life. Currently, there is no standard protocol for differential diagnosis, highlighting the need for a predictive diagnostic model. The study will be a multicenter, prospective machine learning research involving 300 patients across 12 centers. It aims to enhance a previously developed predictive model that integrates machine learning with CT radiomics. Patients will be grouped based on imaging modalities, with data processed uniformly to improve diagnostic predictions. Inclusion criteria ensure comprehensive preoperative data, while exclusion criteria eliminate incomplete or previously treated cases. The study seeks to optimize the model's performance and provide valuable clinical insights.
Trial Details
NCT Number NCT06579768
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: Hospital of Stomatology, Wuhan University, Southern Medical University, China, Second Affiliated Hospital, Zhejiang University, School of Medicine, Xiangya Hospital of Central South University, Air Force Military Medical University, China, The People's Hospital Of QianNan, Central South University, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Hospital of Stomatology, Sun Yat-Sen University, First Affiliated Hospital of Xinjiang Medical University, Guangxi Medical University College of Stomatology
Conditions
(from sponsor)
Jawbone Cysitc Lesion
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov