Longitudinal Monitoring Circulating Tumour Cells(CTC) and Circulatory Tumour DNA (Ctdna) Load in Metastatic colorectal Cancer( Mcrc) and Comparative Analysis with Conventional Assessment Methods.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rudimentary data on utility of CTC and CtDNA in treatment monitoring
研究概览
简要总结
-Proposed prospective study, Out patient clinics and in patient wards of all 3 hospitals -To be conducted in 3 centres of Aster hospital Bangalore- Cmi, Hebbal,Whitefeild and RV.
The study will includes
1.Collection of plasma samples (20ml) from 15 patients diagnosed with metastatic colorectal cancer at 0, 6 and 12 weeks of planned treatment which may include (Palliative chemotherapy, biological therapy , targeted therapy or immunotherapy, surgery and radiation treatment in some cases)
2.Samples subjected to measurement of Circulating tumor DNA, cTDNA load and analysis of pertinent mutations using the iCAn monitor capture assay. This platform contains affinity-based magnetic nanoparticles to mediate EpCAM- based CTC isolation.
3.This longitudinal monitoring and results/responses to treatment will be compared to conventional response assessment methods like Serum CEA measurements and PET CTscan / CT scans (done at 12 weeks as a standard practice in our institution) to guide treatment strategies in metastatic colorectal cancer using statistical methods.
Period of recruitment: 1 year Outcome variables :
1.Detection, levels of CTC and cTDNA load at various time points
2.Correlation with Response assessment using CT scan / PET CT scan
3.Additional assessment – pertinent mutations in liquid biopsy, prevalence and their influence on outcomes .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age above 18years 2.Performance status 0-1 3.Hisologically confirmed invasive colorectal adeno carcinoma 4.Measuramble metastatic disease/M1/STAGE 4colorectal cabncer
- •Patient willing to give informed consent.
排除标准
- •1.Patients diagnosed with stage 1-3 colorectal cancer 2.Poor performance status 3.Patient not willing or not planned for definitive management of colorectal cancer.
结局指标
主要结局
Rudimentary data on utility of CTC and CtDNA in treatment monitoring
时间窗: Collection of blood samples at 0 weeks of planned treatment
in metastatic colorectal cancers.
时间窗: Collection of blood samples at 0 weeks of planned treatment
次要结局
- 1. CTC levels in comparison with conventional response assessment(methods like Serum CEA & cross sectional imaging.)
研究者
Dr Vaishnavi S
Aster CMI Hospital