NCT05853783招募中不适用
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
Proteocyte Diagnostics Inc.5 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.
详细描述
The study objectives are to:
- Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria.
- Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.
- Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system)
- •Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with:
- •No histological evidence of cancer with clinical follow-up data for a period of at least five years; or
- •OSCC development (histologic or documented evidence of invasive cancer).
- •Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center.
排除标准
- •Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients.
- •Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.
结局指标
主要结局
Sensitivity and Specificity
时间窗: 5 years
Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy
Survival analysis
时间窗: 5 years
Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients/biopsies with a STRATICYTE™ classification of Low- and Elevated-Risk.
次要结局
- AUC(5 years)
- C-index (Harrell's)(5 years)
研究者
研究点 (5)
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