Biomarkers for Cancer Treatment
Characterising Circulating Biomarker Signatures From Diverse Cancer Treatment Modalities - A Pilot Study
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).
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Hardip Sandhu, MBA, BSc, MSc, PhD
- 电话号码：+442477 659305
- 邮箱：ab1682@coventry.ac.uk
学习地点
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Coventry、英国、CV2 2DX
- 招聘中
- University Hospitals Coventry & Warwickshire NHS Trust
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首席研究员：
- Raj Shrimali
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接触：
- Raj Shrimali, MBBS, FRCR, FRCP, PhD
- 电话号码：+44 2476 966197
- 邮箱：Raj.Shrimali@uhcw.nhs.uk
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接触：
- Sean James
- 电话号码：+442476 965248
- 邮箱：sean.james@uhcw.nhs.uk
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Patients treated with RT
Patients treated with curative-intent RT/chemo-RT for lung or oesophageal cancer
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Patients treated with SACT
Patients treated with IO-based complex SACT for any malignant solid tumour
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood results
大体时间：Baseline visit
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Identifying and validating changes in miRNA expression
|
Baseline visit
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Blood results
大体时间：12 week follow-up visit
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Identifying and validating changes in miRNA expression
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12 week follow-up visit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood results
大体时间：Baseline visit
|
Identifying and validating changes in protein biomarker profiles
|
Baseline visit
|
|
Blood results
大体时间：12 week follow-up visit
|
Identifying and validating changes in protein biomarker profiles
|
12 week follow-up visit
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.