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Study to Assess the Efficacy and Validation of a QPCR Test for Auxiliary Diagnosis of High Prevalence Cancers Using Whole Blood mRNA

Pilot study to assess the efficacy and validation of a QPCR test for Auxiliary Diagnosis of High Prevalence Cancers using whole blood mRNA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/107355
Enrollment
50
Registered
2026-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C15- Malignant neoplasm of esophagus Health Condition 2: C50- Malignant neoplasm of breast Health Condition 3: C34- Malignant neoplasm of bronchus andlung Health Condition 4: C18- Malignant neoplasm of colon Health Condition 5: C25- Malignant neoplasm of pancreas Health Condition 6: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 7: C53- Malignant neoplasm of cervix uteri Health Condition 8: C22- Malignant neoplasm of liver and intrahepatic bile

Interventions

Intervention1: Nil: Nil

Sponsors

Biomavericks India Pvt ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the QPCR assay in detecting cancer, measured by delta Ct values normalised against GAPDHTimepoint: At the time of sample collection—

Secondary

MeasureTime frame
Area Under the ROC Curve (AUC) to assess the overall discriminative power of the assay across all nine cancer types.Timepoint: At the time of sample analysis;Changes in biomarker expression correlating with treatment response or disease progressionTimepoint: 90 days—

Countries

India

Contacts

Public ContactDr Satish Kumar Agarwal

Indraprastha Apollo Hospitals

mohit_c@apollohospitals.com9650256131

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026