Longitudinal Monitoring Circulating Tumour Cells(CTC) and Circulatory Tumour DNA (Ctdna) Load in Metastatic colorectal Cancer( Mcrc) and Comparative Analysis with Conventional Assessment Methods.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Rudimentary data on utility of CTC and CtDNA in treatment monitoring
Study Overview
Brief Summary
-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 .
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Rudimentary data on utility of CTC and CtDNA in treatment monitoring
Time Frame: Collection of blood samples at 0 weeks of planned treatment
in metastatic colorectal cancers.
Time Frame: Collection of blood samples at 0 weeks of planned treatment
Secondary Outcomes
- 1. CTC levels in comparison with conventional response assessment(methods like Serum CEA & cross sectional imaging.)
Investigators
Dr Vaishnavi S
Aster CMI Hospital