Copenhagen Master Observational Trial (C-MOT): A Prospective Investigator-initiated Observational Study to Study Biomarkers in Relation to Clinical Outcome in Patients With Non-Small Cell Lung Cancer or Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The primary objectives of this prospective non-interventional study (NIS) are to assess and describe outcomes in relation to biomarkers, including whole-genome sequencing (WGS) in patients with non- small cell lung cancer (NSCLC) or breast cancer receiving treatment offered in the clinic (standard of care or included in clinical trials).
详细描述
To date, there have been few studies evaluating the day- to-day effects of non-small cell lung cancer (NSCLC), and advanced (ABC) or metastatic breast cancer (mBC) and its treatment on patients in a real-world setting. There is a gap between the data from the narrowly focused low-quantity, high-quality interventional studies and less granular data collection, high-quantity real world data (RWD). Therefore, prospective, observational trials including all patients independent of biomarkers and collecting comprehensive data on each are needed.
Research question and objectives:
- To describe treatment outcomes based on RWD by a complete set of clinical, socio-psychological, medico-economics data and biospecimens, including whole genome sequencing (WGS) of all patients with breast cancer and NSCLC.
- To record the treatment-related adverse events and late effects experienced by patients based on PRO tools.
- To perform refined biomarker analyses, including (but not limited to) whole genome sequencing, on tumor biopsies at baseline and at progression, in order to identify potential treatment targets.
Study design: Prospective, non-interventional, multicenter study of patients initiating treatment for NSCLC or breast cancer in Copenhagen (Denmark).
Population: Eligible patients will have breast cancer or NSCLC and acceptable performance status and organ function.
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
- •Patients (≥ 18 years of age) with diagnosis of NSCLC or breast cancer amenable to medical or radiation therapy with curative or palliative intent
- •Evidence of a personally signed and dated informed consent form document indicating that the patient has been informed of all pertinent aspects of the study
- •Able to read and understand Danish
- •Willing and able to complete collection of data including WGS
排除标准
- •Patient with breast cancer initiating adjuvant systemic therapy
- •In the judgment of the investigator, the patient's life expectancy is fewer than 3 months at the time of diagnosis of NSCLC or breast cancer
研究组 & 干预措施
Patients with newly diagnosed non-small cell lung cancer
Approximately 1800 patients who are initiating
- Standard of care, including targeted therapy based on PD-L1 status, EGFR, ALK or ROS1 (routine biomarkers)
- Active clinical trials in the clinics after informed consent
干预措施: No Intervention: Observational Cohort (Other)
Patients with metastatic breast cancer
Approximately 600 patients who are initiating
- Standard of care, including targeted therapy based on HER2 status and ER status (routine biomarkers)
- Active clinical trials in the clinics after informed consent
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Progression free survival
时间窗: 3 years
Time from baseline to progression (measured using RECIST v1.1)
Patient reported outcomes
时间窗: 3 years
Health related quality of life. Two istruments will be used: EQ-5D-5L and EORTC QLQ-C30. The EQ-5D-5L will be administered at baseline and after each chemo cycle. The EORTC QLQ-C30 will be administered at baseline and 3 months after baseline.
次要结局
- Adverse events(3 years)
- Late effects(3 years)
- Treatment response(3 years)
- Overall survival(3 years)
研究者
Ulrik Lassen
Head of department
Rigshospitalet, Denmark