NCT05254782招募中不适用
From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Relapse Free Survival
研究概览
简要总结
ctDNALung-Detect is an investigator-initiated single arm, multi-institution study designed to assess the ctDNA detection rate and its association with Relapse Free Survival (RFS) in operable stage T1-T4 (T3,T4 multifocal) N0M0 non-small cell lung cancer (NSCLC) patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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;
- •Ability to provide written informed consent;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection;
- •Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging;
- •Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required.
排除标准
- •Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted.
- •Incomplete surgical resection. Participants who had pre-operative ctDNA samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctDNA testing.
- •Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed.
- •Concurrent active malignancy or other invasive malignancy within previous 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition.
结局指标
主要结局
Relapse Free Survival
时间窗: Up to 36 Months
Relapse free survival (RFS) will be estimated using the Kaplan-Meier method and compared using the logrank test among patients with and without detectable ctDNA pre- or post-operatively.
Rate of ctDNA Detection
时间窗: Up to 24 Months
The percentages of pre-operative and post-operative ctDNA detection in patients with T1-T4N0 (T3, T4 multifocal) NSCLC will be estimated together with their Clopper-Pearson exact 95% CIs.
次要结局
- Overall Survival(Up to 36 Months)
研究者
研究点 (3)
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