Characterising Circulating Biomarker Signatures From Diverse Cancer Treatment Modalities - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Blood results
研究概览
简要总结
Circulating biomarkers, such as miRNAs and proteomics, undergo identifiable and measurable changes during and following treatment for cancer, compared to pre-treatment baseline. Some of these changes may be associated either with known treatment parameters or predictive for cardiac or lung toxicity.
The aim is to identify and validate changes following treatment for cancer, compared to pre-treatment baseline, as well as differential miRNA expression in two-group comparisons (patients receiving radical RT/chemoRT for thoracic cancers versus IO-based complex SACT).
详细描述
To identify and validate changes in miRNA pre- and post- radical RT/chemo-RT (cohort 1) and pre- and post- IO-based complex SACT (cohort 2) and elucidate links between dysregulated miRNAs and clinical evaluations.
To identify and validate changes in protein biomarker profile (1,034 protein targets) pre- and post- radical RT/chemo-RT (cohort 1) and pre- and post- IO-based complex SACT (cohort 2) and to elucidate links between changes in proteins relevant to immune and inflammatory pathways and clinical evaluations.
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
- •Adult patients (Age >18 years)
- •Histologically/Cytological confirmed solid tumour
- •Treated with radical RT or concurrent chemo-RT (Cohort 1) OR
- •Treated with chemo-IO or IO-IO combination (Cohort 2)
- •First-line treatment
- •Able to provide informed consent
- •Willing to comply with study procedures
排除标准
- •Contraindication for RT or chemotherapy (Cohort 1) OR
- •Contraindication for chemotherapy or IO (Cohort 2)
- •Use of chemotherapy or immunotherapy in the last 5 years. (Cohort 1) OR
- •Use of radical RT or chemo-RT within the thorax in the last 5 years. (Cohort 2)
- •Beyond first-line treatment (second line onwards)
- •Has more than 1 active cancer requiring treatment
- •Recent participation in an interventional study
- •Pregnant or breastfeeding women
- •On long term cytotoxics or immune-modulators for rheumatoid arthritis or connective tissue disorders or auto-immune disorders
- •Poor life expectancy, likely less than 6 months
- •Patients not likely to comply with treatment or the study
研究组 & 干预措施
Patients treated with RT
Patients treated with curative-intent RT/chemo-RT for lung or oesophageal cancer
Patients treated with SACT
Patients treated with IO-based complex SACT for any malignant solid tumour
结局指标
主要结局
Blood results
时间窗: Baseline visit
Identifying and validating changes in miRNA expression
Blood results
时间窗: 12 week follow-up visit
Identifying and validating changes in miRNA expression
次要结局
- Blood results(Baseline visit)
- Blood results(12 week follow-up visit)