The Value of Circulating Tumour DNA in Risk Stratification in Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Number of Participants With Detectable Circulating Tumor DNA (ctDNA) in Pre-operative Plasma as Assessed by ddPCR or Targeted NGS
研究概览
简要总结
This study examines circulating tumor DNA (ctDNA) as a biomarker in patients with primary melanoma, prior to surgical excision. The hypothesis is that ctDNA may be detectable in pre-operative blood samples from patients with high-risk primary melanoma, potentially providing a baseline measurement for future disease monitoring.
详细描述
This prospective, single-institution study recruits patients presenting with suspected primary melanoma at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University. Patients with invasive melanoma of stage T3a or higher, or with sentinel node metastasis (N1a or higher), and no distant metastasis (M0) will be selected for final analysis.
Pre-operative blood samples are collected prior to surgical excision. Plasma is harvested and stored. Tumor tissue from excised melanomas is analyzed using next-generation sequencing (NGS, Oncomine Tumor Mutational Load panel) to determine the mutational profile. For patients with targetable mutations, corresponding plasma samples are analyzed for ctDNA using either digital droplet PCR (ddPCR) or plasma NGS depending on the local availability of validated mutation-specific assays.
Enrollment will take place from September 2021 to December 2022, with laboratory analyses expected to be completed in 2025 and final analysis completed by May 2026. This study shares the ethical approval (H-18008586) and biobank infrastructure with a parallel study investigating ctDNA for detection of melanoma recurrence (NCT06246227).
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
- •Age 18 years or older
- •Clinical suspicion of primary cutaneous melanoma
- •Presenting at the Department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital
- •Able to provide written informed consent
排除标准
- •Age less than 18 years
- •Pregnancy
- •Inability to provide written informed consent
研究组 & 干预措施
Primary Melanoma Patients
Patients presenting with suspected primary melanoma prior to surgical excision. Patients that are shown to have invasive melanoma of stage T3a or higher, OR sentinel node metastasis N1a or higher OR distant metastasis M1 or higher, and a targetable tumor mutation in tissue sample are selected for ctDNA analysis.
结局指标
主要结局
Number of Participants With Detectable Circulating Tumor DNA (ctDNA) in Pre-operative Plasma as Assessed by ddPCR or Targeted NGS
时间窗: At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation
A venous blood sample is drawn before surgical excision of the primary melanoma. Plasma is isolated and analyzed for the presence of the same cancer-specific DNA mutation previously identified in the patient's tumor tissue. Two methods are used depending on mutation type: digital droplet PCR (ddPCR, Bio-Rad QX200) for BRAF V600E mutations, or targeted next-generation sequencing (Oncomine Tumor Mutational Load panel, Ion Torrent S5) for other mutations. A sample is classified as "detected" if at least one confirmed mutant DNA copy is identified by ddPCR, or if the tumor-specific variant is present above the assay detection threshold by NGS. The outcome is reported as the number of participants with detected ctDNA out of the total number of participants analyzed.
次要结局
- Number of Participants With Detectable ctDNA by Tumor Stage as Assessed by ddPCR or Targeted NGS(At a single time point prior to surgical excision of the primary melanoma, at the patient's initial clinical presentation.)
研究者
Magnus Petur Bjarnason Obinah
Resident Medical Doctor, PhD Student
Herlev and Gentofte Hospital