A Multicenter, Prospective, Observational Cohort Study of a Dynamic Risk Prediction Model for Treatment-Related Severe Myelosuppression in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,782
- 试验地点
- 1
- 主要终点
- Occurrence of Any Grade 3 or Higher Myelosuppression
研究概览
简要总结
This multicenter, prospective, observational cohort study aims to evaluate a previously developed dynamic risk prediction model for severe treatment-related myelosuppression in patients with nasopharyngeal carcinoma receiving systemic therapy. The model is designed to estimate the risk of grade 3 or higher anemia, thrombocytopenia, and leukopenia or neutropenia during treatment.
Eligible adult patients with histologically confirmed nasopharyngeal carcinoma will be consecutively enrolled at participating centers. Before each cycle of systemic therapy, routinely available clinical and laboratory data will be collected and used to generate updated risk predictions. Patients will be followed throughout systemic therapy and for 28 days after the last treatment.
This is an observational study. Treatment and supportive care will be determined by treating physicians according to routine clinical practice. Model predictions will be used only for research evaluation and will not be used to guide or modify patient treatment. The study will evaluate the predictive performance and clinical applicability of the model across multiple centers.
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
- •Voluntary provision of written informed consent.
- •Age ≥18 years.
- •Histologically confirmed nasopharyngeal carcinoma.
- •Patients who, in the judgment of the treating physician, require systemic anticancer treatment.
排除标准
- •Presence of other uncontrolled serious diseases, including unstable cardiac disease requiring treatment, poorly controlled diabetes mellitus (fasting blood glucose >1.5 times the upper limit of normal), psychiatric disorders, or a history of severe allergy.
- •Considered unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Nasopharyngeal Carcinoma Cohort
Adult patients with histologically confirmed nasopharyngeal carcinoma receiving systemic anticancer therapy as part of routine clinical care will be prospectively enrolled. Clinical and laboratory data will be collected longitudinally during treatment to evaluate the performance of a previously developed dynamic risk prediction model for grade 3 or higher treatment-related myelosuppression. Treatment decisions will not be determined or modified by the study.
结局指标
主要结局
Occurrence of Any Grade 3 or Higher Myelosuppression
时间窗: During each 21-day systemic treatment cycle, from the start of the cycle until the start of the next cycle; for the final cycle, through 28 days after the final systemic treatment.
Occurrence of any grade 3 or higher treatment-related myelosuppression, including anemia, thrombocytopenia, leukopenia, or neutropenia, as assessed during each systemic treatment cycle and after the final systemic treatment.
次要结局
未报告次要终点