The Value of Circulating Tumour DNA in Early Detection of Recurrence of Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 467
- 试验地点
- 2
- 主要终点
- Sensitivity of ctDNA for detection of metastatic disease
研究概览
简要总结
This study examines circulating tumor DNA (ctDNA) as a biomarker for early detection of recurrence in high-risk patients, following treatment of primary melanoma. The hypothesis is that ctDNA can provide accurate detection of recurrence or metastasis, at the time of or earlier than current methods, leading to improved management and hopefully prognosis, based on earlier detection.
详细描述
This prospective, single-institution study will recruit patients attending follow-up for primary melanoma with high risk of recurrence, at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University.
Enrolled patients will undergo regular blood sampling. Samples will be centrifuged and plasma will be harvested and stored. In cases of metastasis or recurrence, tumor tissue samples will be analyzed using NGS to determine their mutational profile. Plasma samples will be analyzed for ctDNA corresponding to identified mutations. If ctDNA is detected, previous samples will be analyzed in reverse sequential order, until no ctDNA is detected.
Follow-up time after inclusion is five years or end of clinical-follow up, with an interim sample and data analysis scheduled for 2024 and final analysis scheduled for 2027-2028.
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
- •Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV
排除标准
- •Pregnancy
- •Previous history of melanoma
研究组 & 干预措施
High Risk Melanoma Patients
Patients followed-up for Melanoma, Clinical Stages IIB - III and Resected Stage IV
结局指标
主要结局
Sensitivity of ctDNA for detection of metastatic disease
时间窗: From enrollment to end of 5-year follow-up
By analyzing blood samples of patients diagnosed with recurrence, we will establish the ability of ctDNA to detect known recurrence, and therefore be able to establish the sensitivity of the method.
Specificity of ctDNA for detection of metastatic disease
时间窗: From enrollment to end of 5-year follow-up
By assuming no ctDNA in healthy individuals and analyzing WBC from buffy-coat to correct for wild-type mutated DNA due to CHIP, we will be able to establish the specificity of the method.
次要结局
- Time from detectable ctDNA to clinical og radiological suspicion of recurrence(From enrollment to end of 5-year follow-up)
- Associations between ctDNA detection and quantification, and other biomarkers, including LDH, WBC differential, and HS-CRP(From enrollment to end of 5-year follow-up)
研究者
Magnus Petur Bjarnason Obinah
Resident Medical Doctor, PhD Student
Herlev and Gentofte Hospital