Improving Early Detection of Melanoma Recurrence With Circulating Tumor DNA (ctDNA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Serum ctDNA acquisition, processing and results
研究概览
简要总结
This is a non-randomized experimental biomarker study evaluating ctDNA levels in patients with stage IIB/C and stage IIIB/C/D melanoma skin cancer pre and post-surgery
Study participants will complete a ctDNA test within 4 weeks of their planned surgical resection of their melanoma. Within 4 weeks post-surgery another ctDNA test will be completed. During these time points stool samples and diet questionnaires will be collected for biospecimen banking.
详细描述
The investigators hypothesize that ctDNA levels drawn before and after surgical resection of a primary tumor and either sentinel lymph nodes or clinically involved metastatic lymph nodes will correlate with the presence of sentinel node microscopic metastatic disease and clinically evident nodal metastatic disease. The investigators also predict that approximately 20% of sentinel lymph node negative Stage IIB/IIC patients will have evidence of ctDNA positivity post-surgery.
Primary Objective:
- To assess the feasibility of generating patient specific ctDNA assay from Signatera© test for primary melanoma samples submitted with clinical stage IIB/IIC and stage III melanoma patients.
Secondary Objective(s):
- To investigate serum levels of melanoma ctDNA pre and postoperatively in clinical Stage IIB/C and Stage III melanoma patients.
- To evaluate the relationship of serum ctDNA levels pre-operatively with sentinel lymph node biopsy status in clinical Stage IIB/C patients.
- Evaluate for clearance or persistence of ctDNA levels post complete resection in patients with clinically evident lymph node metastasis (Stage IIIB/C/D).
- Assess feasibility of collection of pre- and post-operative stool samples
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Serum ctDNA acquisition, processing and results
时间窗: Within 4 weeks pre-surgery through a maximum of 4 weeks post-surgery
The proportion of cases in which sample acquisition, processing and return of results from the two initial ctDNA (serum VAF allele levels, ng/ml) analyses occurs within 6 weeks of acquisition of the post-operative serum sample. The two ctDNA analyses are from the initial tumor biopsy and blood, and post-operative blood draw.
次要结局
- Pre and Post-operative Serum Variant Allele Frequency(Within 4 weeks pre-surgery through a maximum of 4 weeks post-surgery)
- Pre and Post-operative Stool Samples(Within 4 weeks pre-surgery through a maximum of 4 weeks post-surgery)
- The proportion of patients for which serum VAF levels (ng/ml) are undetectable post complete resection of either sentinel nodes or clinically evident lymph node metastases(Within 4 weeks post-surgery)
- Pre-operative serum VAF levels (ng/mL) from Signatera© stratified by pre-operative sentinel lymph node and clinically evident lymph node metastatic status.(Within 4 weeks post-surgery)
- Quantify the number of patients who develop detectable VAF levels (ng/ml) within the first 3 years after surgery and evaluate possible correlation with recurrence.(3 years post resection of the last patient enrolled.)
- Association of pre-operative and post-operative serum Variant allele frequency (VAF) levels (ng/ml) from the Signatera© test and sentinel lymph node biopsy metastatic status(Within 4 weeks pre-surgery)