SjoTrace-cfRNA: a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis and Tissue-source Tracing in Sjögren's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- AUC of model
研究概览
简要总结
The goal of this observational study is to learn whether salivary cell-free RNA (cfRNA) can be used as a non-invasive liquid biopsy test to help diagnose Sjögren's disease (SjD) and understand disease-related changes in the salivary glands. The main questions it aims to answer are:
- Can salivary cfRNA distinguish patients with SjD from people with sicca symptoms who do not have SjD?
- Are salivary cfRNA signals associated with clinical features of SjD, such as autoantibody-related immune activity and salivary gland pathology?
- Can salivary cfRNA signals be linked to specific cell types and tissue regions in the salivary glands? Participants will provide saliva samples, and clinical information from routine medical evaluation will be collected. Some available salivary gland tissue transcriptomic data will also be analyzed to explore the possible tissue sources of salivary cfRNA signals.
详细描述
This observational study will evaluate SjoTrace, a salivary cell-free RNA (cfRNA)-based liquid biopsy approach for Sjögren's disease (SjD). SjD is an autoimmune disease that often affects the salivary glands and causes dryness symptoms, but diagnosis can be challenging because sicca symptoms may also occur in people without SjD.
In this study, saliva samples will be collected from participants with SjD and from non-SjD sicca control participants as part of an observational research protocol. Salivary cfRNA profiles will be analyzed to identify RNA features associated with SjD. Machine-learning methods will be used to develop and evaluate a cfRNA-based diagnostic score.
The study will also explore whether salivary cfRNA signals are related to clinical features of SjD, including immune-related laboratory findings and salivary gland pathology. In addition, transcriptomic datasets from salivary gland tissue, including bulk RNA sequencing, single-cell RNA sequencing, and spatial transcriptomic data, will be analyzed to investigate the possible tissue and cellular sources of disease-associated cfRNA signals.
This study does not assign participants to any treatment or intervention. All clinical care decisions will be made by the participants' regular health care providers. The research is intended to assess the diagnostic and biological value of salivary cfRNA as a non-invasive tool for SjD evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years
- •Fulfilled the 2016 ACR/EULAR classification criteria for Sjögren's disease
- •Newly diagnosed or previously diagnosed with complete diagnostic evidence available
- •Willing to provide clinical data and saliva samples
- •Provided written informed consent
- •Non-SjD sicca control group:
- •Aged 18-65 years
- •Frequency-matched with the case group by sex and age
- •No personal or family history of autoimmune diseases
- •No persistent symptoms suggestive of SjD (e.g., dry mouth or dry eyes), with physical examination and necessary laboratory test results within normal limits
- •Willing to provide clinical data and saliva samples
- •Provided written informed consent
排除标准
- •Malignant tumors or severe active infections
- •Pregnancy or lactation
- •Use of biologics or potent immunosuppressive therapy within the past 3 months that could significantly alter study indicators (patients included due to strict clinical necessity will be recorded and utilized for sensitivity analysis)
- •Severe hepatic or renal impairment, or other diseases that significantly interfere with cfRNA detection
- •Failure to meet the standardized oral status, fasting, or sampling timing requirements prior to collection, with resampling being impossible
- •Incomplete clinical data
- •Substandard collection, preservation, or quality control of saliva or labial gland tissue samples
- •Any other conditions deemed unsuitable for participation by the investigator
研究组 & 干预措施
SjD Participants
Participants will include individuals diagnosed with Sjögren's disease (SjD)
Non-SjD Sicca Participants
individuals with sicca symptoms who do not meet diagnostic criteria for SjD
结局指标
主要结局
AUC of model
时间窗: half a year
The primary endpoint is the area under the receiver operating characteristic curve (AUC) of SjDTrace in the independent validation cohort.
次要结局
未报告次要终点