Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Adjuvant Melanoma Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Identify a pattern for gene recognition of cancer recurrence earlier than standard of care.
研究概览
简要总结
To generate meaningful data regarding ctDNA that would infer risk of recurrence in stage III melanoma patients.
详细描述
Cancer cells harbor and can acquire potentially hundreds of mutations, many of whom are found in the ctDNA. Circulating tumor DNA (ctDNA) holds the promise for the 50% of participants who do not need adjuvant therapies - participants could be monitored to ensure no increase in ctDNA. Participants treated could then be followed for the earliest possible blood level signs of recurrence (incr. ctDNA) and more quickly be switched to more effective therapies. Further, the treating physician could hold therapy until the first signs of ctDNA based recurrence for those participants that would benefit.
Blood sample from a biobank will be used to identify to monitor ctDNA. These blood samples were drawn at baseline, 3 months, 6 months and 18 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Confirmed fully resected Stage IIIb-IV cutaneous melanoma; including patients treated neoadjuvantly within three months prior to resection.
排除标准
- •Treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 Study Design
结局指标
主要结局
Identify a pattern for gene recognition of cancer recurrence earlier than standard of care.
时间窗: samples taken at baseline, 3 months, 6 months and 18 months.
Genomic sequencing of 40+ ctDNA genes will be analyzed to identify genetic alterations correlating with the development of recurrence in melanoma.
次要结局
- Analyze the genetic pathway associated with cancer recurrence and biologic information.(samples taken at baseline, 3 months, 6 months and 18 months.)