| CTRI Number |
CTRI/2026/03/105171 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
VarSee clinical validation study |
|
Scientific Title of Study
|
Multicentre prospective & retrospective remnant Biospecimen collection program for study and future biomedical research |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SSC-BM-01-2024 version 1 date 23.07.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Patel |
| Designation |
Principal Investigator and Consultant Medical Oncologist |
| Affiliation |
Shlok Superspecialty Care |
| Address |
Clinical trial department, 4th floor, Shlok Superspecialty Care Opposite Radhaswami Samyak
Lambhvel Rd Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9974169880 |
| Fax |
|
| Email |
akash.patel422462@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snahlata Singh |
| Designation |
Chief Scientific Officer |
| Affiliation |
BioMarkIQ Scientific Technologies Private Limited |
| Address |
BioMarkIQ Lab, G1 Block, Atal Incubation Centre, Indian Institute of Science Education & Research, Pune
Pune
MAHARASHTRA
411008
India |
| Phone |
7499159787 |
| Fax |
|
| Email |
snahlata.singh@biomarkiq.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snahlata Singh |
| Designation |
Chief Scientific Officer |
| Affiliation |
BioMarkIQ Scientific Technologies Private Limited |
| Address |
BioMarkIQ Lab, G1 Block, Atal Incubation Centre, Indian Institute of Science Education & Research, Pune
Pune
MAHARASHTRA
411008
India |
| Phone |
7499159787 |
| Fax |
|
| Email |
snahlata.singh@biomarkiq.com |
|
|
Source of Monetary or Material Support
|
| BioMarkIQ Scientific Technologies Private Limited |
|
|
Primary Sponsor
|
| Name |
BioMarkIQ Scientific Technologies Private Limited |
| Address |
Aryan Home Flat No. 102, Sr No. 31/2B/14,27, 2B, Village
Baner, Taluka Haveli - 411045, District Pune, Baner Gaon,
Pune, Haveli, Maharashtra, India, 411045 |
| Type of Sponsor |
Other [Startup registered as private limited] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BioMarkIQ Scientific Technologies Private Limited |
Aryan Home Flat No. 102, Sr No. 31/2B/14,27, 2B, Village
Baner, Taluka Haveli - 411045, District Pune, Baner Gaon,
Pune, Haveli, Maharashtra, India, 411045 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja Pandya |
Parikh Multispeciality Hospital |
Clinical Research Room, Research Department, Bhagwati Park, Near Tube Company, A/4, Old Padra Road, Opp. Gajanad Complex, Akota, Vadodara 390007, Gujarat
Vadodara
GUJARAT |
92658 89916
puja@shlokhospitals.com |
| Dr Akash Patel |
Shlok Superspecialty Care |
Clinical trial department, 4th floor, Shlok Superspecialty Care Opposite Radhaswami Samyak
Lambhvel Rd Anand Gujarat
Anand
GUJARAT |
9974169880
akash.patel422462@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shlok Superspeciality Care |
Approved |
| Institutional Ethics Committee, Shlok Superspeciality Care |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed lung cancer patients with confirmed
tissue biopsy and CT scan and no treatment or surgery before enrollment. Inclusion
criteria for cancer cohort |
|
| ExclusionCriteria |
| Details |
Pediatric lung cancer patients, patients with history of
previous cancers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the panel of most sensitive and specific biomarkers amongst the 12 candidate protein biomarkers that can yield a sensitivity of more than 90%.
To assess the sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC-ROC) of the biomarker panel for lung cancer diagnosis.
To compare the diagnostic performance of individual biomarkers within the shortlisted panel and compare them with the entire panel.
|
At the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between biomarker levels and tumor characteristics, such as tumor size, histological subtype, or stage of lung cancer. |
At the baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/03/2026 |
| 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) |
Open to Recruitment |
|
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
|
This is a retrospective, case-control exploratory study designed to evaluate the diagnostic accuracy of a novel panel of circulating blood biomarkers in differentiating lung cancer patients from healthy individuals. A total of 120 participants will be recruited, including 70 lung cancer patients (both treatment-naive and undergoing therapy) and 50 healthy volunteers. Blood samples will be analyzed using immunoassay to quantify biomarker levels, which will be processed through a clinical inference tool (VarSee) to generate diagnostic scores. The study aims to assess sensitivity, specificity, predictive values, and AUC-ROC of individual and combined biomarkers. This research intends to offer a non-invasive, cost-effective alternative to current diagnostic modalities like LDCT for early lung cancer detection in high-risk populations. |