Title: Cancer screening using liquid biopsy stem cell-based tests 

Milestone: To demonstrate the feasibility of stem cell-based tests for determination of cancer presence in a larger cohort.

Study Design: 12 ml of blood sample will be collected from all eligible subjects for the study. 

Type of trial/study: Prospective and Observational

Objectives:

1. To assess the feasibility of Raman Spectroscopy as a screening tool for cancer detection 

2. To isolate circulating stem cells from peripheral blood of cancer and non-cancer subjects and determine expression patterns of various markers by droplet digital PCR (ddPCR) and quantitative PCR (qPCR).

3. To isolate and enumerate rare stem cells and progenitors from peripheral blood of healthy individuals and cancer patients.

4. To assess the potential of BCube test (Next Generation Sequencing of stem cells/ cancer stem cells/ progenitors enriched from the peripheral blood) for identification of transcriptomic profile to evaluate the systemic malignancy.

5. To characterize the exomic profile and evaluate its potential to distinguish cancer patients from healthy controls.

6. To achieve adequate statistical power, reliability and robustness of study findings and develop robust data base with adequate statistical power and reliability by increasing sample size.

Expected outcome:

1. Identification of cancer and non-cancer subjects using biochemical fingerprints of Raman Spectroscopy, expression patterns of ddPCR / qPCR and Flow Cytometry.

2. Identification of primary impacted organ using altered gene expression patterns and mutations profile wherever applicable.

Conclusions: To demonstrate the potential of our technology as a screening tool for identification of cancer and non-cancer status of an individual through biochemical fingerprints of Raman Spectroscopy, expression patterns of ddPCR / qPCR and Flow Cytometry panel, and to demonstrate potential of altered gene expression patterns and mutations profile to identify primary impacted organ.