Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Disease progression
研究概览
简要总结
The INNOVA project aims to create an advanced multidisciplinary diagnostic platform to support the Italian healthcare system and translational research. In this context, WP7, coordinated by the Pascale Institute and the focus of this study protocol, is responsible for developing a national platform for the multi-omic profiling of cancer patients eligible for precision medicine treatments, with the goal of supporting clinical decision-making.
详细描述
The study is multicentric, observational, non-interventional, and both prospective and retrospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to participate in the study
- •Age >18 years
- •Performance status (PS) 0-1
- •Availability of biological samples for multi-omic profiling
- •Availability of radiological images for radiomic assessments
- •Patients with metastatic disease, i.e., stage IV (except for melanoma, where stage II/III patients eligible for adjuvant therapy may also be considered)
- •Patients eligible for targeted therapy and/or immunotherapy
- •Patients with aggressive neoplasms, including melanoma, non-small cell lung carcinoma (NSCLC), colon carcinoma (BRAF-mutated, MSI), triple-negative breast cancer, ovarian cancer, and cholangiocarcinoma.
排除标准
- •Previous line of immunotherapy or targeted therapy
- •Previous radiotherapy at the sites of the most recent diagnostic biopsy
- •Most recent diagnostic biopsy performed >24 months before enrollment
- •Absence of measurable lesions
- •Presence of active or untreated brain metastases or leptomeningeal carcinomatosis
结局指标
主要结局
Disease progression
时间窗: approximately 3 years
Rate of metastatic patients with disease progression (PD) within 3 months from the start of targeted therapy and/or immunotherapy, or disease recurrence rate at 6 months in patients undergoing adjuvant therapy.
次要结局
未报告次要终点