Significance of Detection and Quantification of Circulating Tumor DNA in the Treatment of Melanoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters
研究概览
简要总结
The aim of this prospective clinical study is to determine whether the presence and quantity of circulating tumor DNA (ctDNA) can serve as a predictive factor for recurrence or progression of melanoma. The study evaluates the association between ctDNA detection and quantification and relevant clinical and histopathological prognostic parameters. The goal is to assess whether ctDNA may be useful as a biomarker for monitoring disease course and predicting outcomes in melanoma patients.
详细描述
This is a prospective clinical study evaluating the clinical significance of circulating tumor DNA (ctDNA) detection and quantification in patients with melanoma. The main purpose of the study is to determine whether the presence and quantity of ctDNA may represent a predictive biomarker for melanoma recurrence or disease progression.
The study assesses the relationship between ctDNA levels and established clinical and histopathological prognostic factors. ctDNA detection and quantification are performed and correlated with relevant patient and tumor characteristics. The study also evaluates whether ctDNA measurement can contribute to improved monitoring of melanoma patients and prediction of disease course.
The study is conducted at the Institute of Oncology Ljubljana and includes melanoma patients who are followed over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients (≥ 18 years).
- •Patients with histologically confirmed melanoma.
- •Patients undergoing treatment and/or follow-up at the Institute of Oncology Ljubljana.
- •Availability of clinical follow-up data to assess recurrence or progression.
- •Ability to provide blood samples for ctDNA analysis.
- •Signed informed consent.
排除标准
- •Patients unable to provide blood samples.
- •Patients with missing clinical or histopathological data required for analysis.
- •Any condition that, in the investigator's opinion, makes the patient unsuitable for participation.
研究组 & 干预措施
ctDNA Monitoring Cohort
Patients with histologically confirmed melanoma are monitored for the presence and quantity of circulating tumor DNA (ctDNA) during follow-up in order to evaluate the association between ctDNA and recurrence or progression of disease.
干预措施: Blood Sampling for ctDNA Analysis (Other)
结局指标
主要结局
Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters
时间窗: Baseline and during follow-up up to 24 months
Circulating tumor DNA (ctDNA) will be measured in peripheral blood plasma using a validated molecular assay (e.g., digital droplet PCR and/or next-generation sequencing). ctDNA will be reported as detectable vs. non-detectable and as ctDNA concentration (copies/mL). Correlation between ctDNA results and clinical/histopathological prognostic parameters (e.g., AJCC stage, Breslow thickness, ulceration status, and metastatic status) will be assessed.
次要结局
- Recurrence or Progression of Melanoma(From baseline up to 24 months)