RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Success rate for tumor RNA isolation and amplification
研究概览
简要总结
The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:
- •18 years of age or older.
- •Suspected RCC, in the opinion of the investigator
- •Availability of either:
- •Nephrectomy or other surgically removed tissue (Stage I); or,
- •Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II).
- •≥5 biopsy specimens available from BRPC.
- •Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol.
- •Not currently being treated with systemic therapy.
排除标准
- •Tumor tissue is committed to other use or inadequate for RNA analysis.
- •Insufficient tissue is collected in the BRPC.
- •Expansion Cohort for Genitourinary Cancers:
- •Inclusion Criteria:
- •18 years of age or older
- •Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.
- •Availability of surgically removed tissue or biopsy tissue.
- •At least 2 biopsy specimens available from BRPC
- •Not currently being treated with systemic therapy.
- •Exclusion Criteria:
- •Tumor tissue is committed to other use or inadequate for RNA analysis.
- •Insufficient tissue is collected in the BRPC.
研究组 & 干预措施
Renal Cell Carcinoma Tumor Tissue
干预措施: RNA extraction and amplification from biopsy specimens (Device)
Genitourinary tumor tissue (Expansion cohort)
Bladder, prostate or testicular cancer
干预措施: RNA extraction and amplification from biopsy specimens (Device)
结局指标
主要结局
Success rate for tumor RNA isolation and amplification
时间窗: At time of surgery or during biopsy
To Determine the success rate for tumor RNA isolation and amplification create a minimum of 10 doses of AGS-003, as defined by a minimum concentration of ≥84 µg/µL in typically greater than 150 µL final volume RNA. (Tissue obtained at time of surgery or biopsy depending on stage)
次要结局
未报告次要终点