Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparative and complementary in operable patients diagnosed with cancer
研究概览
简要总结
Early diagnosis of these cancers is a public health priority. Additionally, early detection of recurrences after treatment is crucial for optimizing disease management.
This study seeks to demonstrate the accuracy of the Rarecells ISET® circulating tumor cells DNA (CTC-DNA), combined with circulating tumor DNA (ctDNA), for the early diagnosis of lung cancer.
详细描述
Researching for tumor biomarkers in the blood, circulating tumor cells (CTCs), and circulating tumor DNA (ctDNA) can non-invasively detect signs of cancer without risk to the patient. These are ideal and risk-free methods for monitoring patients and early detection of lung cancer.
This study aims to assess the sensitivity of molecular analyses performed on circulating tumor DNA in the blood and on DNA from circulating tumor cells, isolated using the highly sensitive ISET® method. The purpose is to assess two circulating molecular biomarkers in the field of liquid biopsy in patients with lung cancer: Rarecells ISET® CTC-DNA and ctDNA.
Subjects eligible for inclusion in the study are individuals diagnosed with operable lung cancer who will undergo biopsy or surgical resection of the tumor. Upon enrolment in the trial, participants will undergo an assessment including low-dose CT scan, isolation of CTCs by the ISET® method, and separation of plasma for analysis of ctDNA.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 35 and 85 years
- •Patient diagnosed with resectable lung cancer (by imaging and/or pathological examination) not yet treated for this cancer.
- •Patient capable of giving free, informed, and express consent
- •The assessment of successful elected surgery implies, but is not limited to, the following:
- •Exclusion of detectable extra thoracic and distant metastases
- •Determination of the presence or absence of superior mediastinal lymph node metastases
- •Definition of the histologic or cell type, whenever possible
- •Evaluation of operative risk
排除标准
- •Patient diagnosed and/or treated previously for lung cancer or another cancer, regardless of duration
- •Patient treated with neoadjuvant treatment
- •Pregnant women
- •Patient presenting psychiatric or neurological disorders preventing them from understanding the research
结局指标
主要结局
Comparative and complementary in operable patients diagnosed with cancer
时间窗: 30 days post procedure
Number of patients with lung cancer-related mutations by CTCDNA alone, by ctDNA alone and by the ctDNA -CTCDNA pair divided by the number of patients with cancer enrolled in the study
次要结局
- Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype(30 days post procedure)