Pilot study to assess the efficacy and validation of a QPCR test for Auxiliary Diagnosis of High Prevalence Cancers using whole blood mRNA
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Biomavericks India Pvt ltd
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity of the QPCR assay in detecting cancer, measured by delta Ct values normalised against GAPDH
Overview
Brief Summary
Cancer remains a leading cause of morbidity and mortality worldwide, with many cases diagnosed at advanced stages when treatment is less effective. Early detection significantly improves patient outcomes. This pilot study aims to validate a novel QPCR-based leukocyte mRNA biomarker test for auxiliary diagnosis of nine high-prevalence cancer types including breast, lung, colorectal, esophageal, pancreatic, oral, cervical, hepatic, and gastric cancers. The test measures immunosuppression through peripheral blood mononuclear cell derived leukocyte mRNA biomarkers, providing a minimally invasive alternative to conventional imaging and liquid biopsy methods. Approximately 50 diagnosed cancer patients (stages 1-4) aged 18-80 years will be enrolled. Blood samples will be collected at screening, processed for RNA extraction, cDNA synthesis, and qPCR analysis. The primary outcome is sensitivity and specificity of the assay measured by delta delta Ct values normalized against GAPDH. Secondary outcomes include accuracy in cancer type identification and biomarker expression changes correlating with treatment response and disease progression. This study is expected to demonstrate the diagnostic potential of PBMC-based biomarkers and establish a standardized clinical pathway for integration of this auxiliary diagnostic tool into routine cancer care, ultimately improving early detection and patient outcomes.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18-80 years at informed consent signing; Diagnosed with one of specified cancers (Breast, Lung, Colorectal, Esophageal, Pancreatic, Oral, Cervical, Liver, Gastric); Newly diagnosed cancer patients; Cancer Stages 1-4; Histologically or cytologically confirmed diagnosis; Ability to provide informed consent.
Exclusion Criteria
- •Blood disorders interfering with results; Active cancer treatment (chemotherapy, radiotherapy, immunotherapy); Severe comorbidities including hepatic disease (encephalopathy, ascites, jaundice, variceal bleeding, cirrhosis); Major surgical procedures within 60 days or planned during study; Active infections; Known Hepatitis B or C (acute or chronic); Pregnancy or lactation; Inability to comply with protocol and follow-up.
Outcomes
Primary Outcomes
Sensitivity and specificity of the QPCR assay in detecting cancer, measured by delta Ct values normalised against GAPDH
Time Frame: At the time of sample collection
Secondary Outcomes
- Area Under the ROC Curve (AUC) to assess the overall discriminative power of the assay across all nine cancer types.(At the time of sample analysis)
- Changes in biomarker expression correlating with treatment response or disease progression(90 days)
Investigators
Dr Mohit Chowdhary
Indraprastha Apollo Hospitals