Ultrasensitive Chromosomal Aneuploidy Detection (UCAD) in Urine Exfoliated Cells for Diagnosis of Urothelial Carcinoma in in Urine Exfoliated Cells
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Sensitivity of urinalysis by UCAD analysis
研究概览
简要总结
Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA extracted from urothelial cells in urine samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of bladder cancer patients. CIN can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. We here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CIN thus help diagnosing and treating bladder cancer patients.
详细描述
CIN results from errors in chromosome segregation during mitosis, leading to structural and numerical chromosomal abnormalities. It will generate genomic heterogeneity that acts as a substrate for natural selection. Furthermore, it is proved that tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with metastasis, treatment resistance, and decreased overall survival. It is estimated that 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively correlates with tumor stage and is enriched in relapsed as well as metastatic tumor specimens. Due to the ubiquity of CIN in cancer cells, it is a potentially non-invasive way to detect CIN in the urothelial cells from the urine sample for diagnosing and monitoring bladder cancer patients. UCAD is a new method to detecting CIN in the DNA sample from patients, including extracting DNA from urine, analyzing DNA by low-coverage whole-genome sequencing, processing the data by bio-information techniques, and finally optimizing the management of bladder cancer patients.
The investigators intended to conduct a prospective study by analyzing urine samples from bladder cancer patients and control groups that without any tumor in the urinary system or other organs to compare the specificity and sensitivity of UCAD test for diagnosing urothelial carcinoma to other modalities, such as urine cytology or fluorescence in situ hybridization (FISH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients diagnosed with urothelial carcinoma and planned to undergo surgery.
- •Participants without any tumor disease and willing to attend the study by providing morning urine.
- •Male or female patients aged >= 18 years.
- •Participants signed informed consent form.
排除标准
- •Age under 18 years
- •Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record.
- •Individuals unwilling to participate in this trial.
结局指标
主要结局
Sensitivity of urinalysis by UCAD analysis
时间窗: Up to 1 years
Number of patients "declared positive" with the UCAD test among the patients suffered from urothelial carcinoma.
Specificity of urinalysis by UCAD analysis
时间窗: Through study completion, an average of 12 months
Number of patients "declared negative" with the UCAD test among the patients without cancer.
次要结局
- Comparison of the specificity of the UCAD analysis versus urine cytology(Up to 1 years)
- Comparison of the sensitivity of the UCAD analysis versus urine cytology(Up to 1 years)
研究者
Shuxiong Zeng
Principal Investigator
Changhai Hospital