Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Positive predictive value (PPV) of circulating tumor DNA in Cohort I
研究概览
简要总结
This study will evaluate the utility of ctDNA detection in patients with high-risk stage I, stage II, and stage III germ cell tumor disease to develop a tool for post-treatment cancer cell detection.
详细描述
This is a specimen collection study where patients with high-risk stage I germ cell tumor, clinical stage II germ cell tumor, and clinical stage III germ cell tumor will be evaluated for ctDNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •≥ 18 years old at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization
- •Subjects must have histologically or serologically confirmed seminomatous or non seminomatous germ cell tumor. Non-seminoma includes embryonal carcinoma, choriocarcinoma, yolk sac tumor, or teratoma.
- •Note: Cohort I is for high-risk clinical stage I disease (high risk will be defined as per enrolling investigator discretion). Cohort II is for clinical stage II. Cohort III is for clinical stage III or IS.
- •Archival tissue for germ-cell tumor diagnosis available
排除标准
- •Concurrent disease or condition that would make the subject inappropriate for study participation
- •Any serious medical disorder that would interfere with the subject's safety
- •Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent per treating physician coverage.
- •Patient is being tested for minimal residual disease with other experimental platforms
研究组 & 干预措施
Cohort I - High Risk Clinical stage I
50 subjects will be enrolled with high-risk stage I seminomatous or non-seminomatous germ cell tumors. In these patients, ctDNA will be collected post-orchiectomy prior to initiation of surveillance and every 4 months during surveillance for up to 2 years.
干预措施: Whole blood for ctDNA (Diagnostic Test)
Cohort II- Clinical stage II
30 patients will be enrolled with clinical Stage II seminomatous or non-seminomatous germ cell tumor who are planning to undergo primary resection with RPLND. In these patients, ctDNA will be collected prior to surgery and every 4 months after surgery for up to 2 years.
干预措施: Whole blood for ctDNA (Diagnostic Test)
Cohort III- Clinical stage III
50 patients will be enrolled with clinical Stage III (or IS) seminomatous or non-seminomatous germ cell tumor who are planning to undergo first-line chemotherapy. In these patients, ctDNA will be collected prior to chemotherapy, at cycle 2 day 1, within 28 days of starting last cycle of chemotherapy, and every 4 months after completing chemotherapy.
干预措施: Whole blood for ctDNA (Diagnostic Test)
结局指标
主要结局
Positive predictive value (PPV) of circulating tumor DNA in Cohort I
时间窗: At screening and every 4 months up to 2 years
PPV will be calculated as the number of true positives divided by the total number of positive tests in patients with high-risk stage I germ cell tumor.
Positive predictive value (PPV) of circulating tumor DNA in Cohort II
时间窗: At screening and every 4 months up to 2 years
PPV will be calculated as the number of true positives divided by the total number of positive tests in the node dissection patients with clinical stage II germ cell tumor.
Positive predictive value (PPV) of circulating tumor DNA in Cohort III
时间窗: At screening and every 4 months up to 2 years
PPV will be calculated as the number of true positives divided by the total number of positive tests in the first-line chemotherapy patients with clinical stage III germ cell tumor.
次要结局
- Negative predictive value (NPV) of circulating tumor DNA in Cohort I(At screening and every 4 months up to 2 years)
- Negative predictive value (NPV) of circulating tumor DNA in Cohort II(At screening and every 4 months up to 2 years)
- Negative predictive value (NPV) of circulating tumor DNA in Cohort III(At screening and every 4 months up to 2 years)
- Post-node dissection circulating tumor DNA bioassay(At screening and every 4 months up to 2 years)
- Post-node dissection clearance rate of ctDNA(At screening and every 4 months up to 2 years)
研究者
Nabil Adra
Associate Professor of Clinical Medicine
Indiana University