| CTRI Number |
CTRI/2026/04/107355 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Assess the Efficacy and Validation of a QPCR Test for
Auxiliary Diagnosis of High Prevalence Cancers Using Whole Blood mRNA |
|
Scientific Title of Study
|
Pilot study to assess the efficacy and validation of a QPCR test for Auxiliary Diagnosis of High Prevalence Cancers using whole blood mRNA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIOMS_AP_02_02_MAY_2025_V2.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Chowdhary |
| Designation |
Principal Investigator |
| Affiliation |
Indraprastha Apollo Hospitals |
| Address |
Dr Mohit Chowdhary, Ground floor, Blood Bank, near Gate 9, Department of Immunology & Transfusion Medicine, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9650256131 |
| Fax |
|
| Email |
mohit_c@apollohospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Chowdhary |
| Designation |
Principal Investigator |
| Affiliation |
Indraprastha Apollo Hospitals |
| Address |
Dr Mohit Chowdhary, Ground floor, Blood Bank, near Gate 9, Department of Immunology & Transfusion Medicine, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi
DELHI
110076
India |
| Phone |
9650256131 |
| Fax |
|
| Email |
mohit_c@apollohospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Kumar Agarwal |
| Designation |
Study Coordinator / Scientific Contact |
| Affiliation |
Indraprastha Apollo Hospitals |
| Address |
Dr Satish Kumar Agarwal, ARAI, Basement, Hostel complex building, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9811025001 |
| Fax |
|
| Email |
drsatish_a@apollohospitals.com |
|
|
Source of Monetary or Material Support
|
| 1. Material Support -Biomavericks India Pvt Ltd
2. Infrastructure support - Apollo Indraprastha Hospital |
|
|
Primary Sponsor
|
| Name |
Biomavericks India Pvt ltd |
| Address |
BLK-B-6 Model Town, PH-1, Model Town II,. New Delhi, 110009, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohit Chowdhary |
Indraprastha Apollo Hospitals |
Dr Mohit Chowdhary, Ground floor, Blood Bank, near Gate 9, Department of Immunology & Transfusion Medicine, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi
New Delhi
DELHI |
9650256131
mohit_c@apollohospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Clinical Studies, Indraprastha Apollo Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (2) ICD-10 Condition: C50||Malignant neoplasm of breast, (3) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, (4) ICD-10 Condition: C18||Malignant neoplasm of colon, (5) ICD-10 Condition: C25||Malignant neoplasm of pancreas, (6) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (7) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, (8) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, (9) ICD-10 Condition: C16||Malignant neoplasm of stomach, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of the QPCR assay in detecting cancer, measured by delta Ct values normalised against GAPDH |
At the time of sample collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |