Development of a Blood Test of Anti-IMP3 Autoantibody and Serum MicroRNA Signature for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Presence of primary and/or metastatic renal cell carcinoma by IMP3 autoantibody
研究概览
简要总结
This research trial studies the development of a blood test for detecting anti-insulin-like growth factor II mRNA binding protein 3 (anti-IMP3) antibody and micro ribonucleic acid (microRNA) in patients with renal cell carcinoma (RCC) that has spread to other parts of the body (metastatic) or is limited to the tissue or organ where it began (localized). Anti-IMP3 is a tumor marker that can be detected in many human cancers, including RCC and is likely to be present in the serum (blood) of patients with metastatic or localized RCC. Alterations in microRNA expression has also shown to play a critical role in cancer progression and may be a promising biomarker for patients with RCC. Developing a blood test for anti-IMP3 antibody and microRNA in serum and tissue samples of patients in the laboratory may help doctors find and diagnose RCC earlier, find out how far the disease has spread, and plan effective treatment for RCC.
详细描述
PRIMARY OBJECTIVE:
I. To develop a blood test by monitoring the titer of IMP3 autoantibody and/or microRNA (miRNA)/small non-coding RNA (snRNA) expression in patients' serum for the early detection of RCC and its recurrence/metastasis.
OUTLINE: Serum samples are collected prior to treatment and analyzed for anti-IMP3 autoantibody titer via enzyme-linked immunosorbent assay (ELISA) and total RNA via sequencing, microarray, and/or quantitative polymerase chain reaction (q-PCR). Previously collected tissue samples are analyzed for IMP3 via immunohistochemistry (IHC).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic RCC Patients' Serum Cohort:
- •a. Serum samples from patients with metastatic RCC prior to surgical removal of the metastatic and/or primary lesions
- •b. Serum samples from patients with localized RCC prior to surgical removal of the lesions
- •c. Discarded donors' and patients' discarded/leftover plasma/serum samples from blood bank and other Department of Pathology laboratories
- •d. Serum samples from patients with metastatic RCC who had nephrectomies or/and RCC-related biopsies in the referring hospitals
- •Metastatic RCC Patients' Tissue Cohort:
- •Formalin-fixed paraffin-embedded (FFPE) and/or frozen primary and/or metastatic RCC tissue samples from the corresponding patients serum who are included in inclusion criteria (a-b)
- •FFPE and/or frozen benign renal tissue samples which are nearby the tumor and remove during surgical procedures from the corresponding patients who are included in inclusion criteria (a-b)
- •Discarded/leftover FFPE and frozen renal tissue samples from Department of Anatomic Pathology and its Tumor Bank
- •FFPE primary and/or metastatic RCC tissue samples (unstained slides) from the corresponding patients who are included in inclusion criteria (d)
排除标准
- •Not applicable
结局指标
主要结局
Presence of primary and/or metastatic renal cell carcinoma by IMP3 autoantibody
时间窗: Baseline
For the IMP3 autoantibody study, the results of IHC studies of IMP3 on the tissue sections will be used as golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P \< 0.05 (confidence level of 95%).
Presence of primary and/or metastatic renal cell carcinoma by miRNA/snRNA signature
时间窗: Baseline
For the miRNA/snRNA signature study, the patients' clinical presentation of RCC and its recurrence/metastasis will be used as the golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P \< 0.05 (confidence level of 95%).
次要结局
未报告次要终点