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Multi-Centre Diagnostic Accuracy Study of VarSee for Early Detection of Lung Cancer

VarSee Diagnostic Accuracy Study: A Multi-Centric Trial for Detection of Lung Cancer Using an Advanced Diagnostic System - VarSee

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/098156
Enrollment
1000
Registered
2025-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Lung cancer cohort: Blood will be drawn from lung cancer patients before any therapy or surgery begins. Control Intervention1: Healthy co

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for lung cancer patients 1. Age equal to or above 18 years (both male and female). 2. Confirmed Diagnosis: Lung cancer diagnosis confirmed by tissue biopsy, with a report available. 3. Imaging and Blood Reports: Availability of CT and Complete Blood Count (CBC) reports. 4. No Prior Cancer Treatment: Patients who have not undergone chemotherapy, radiation therapy, or surgery before enrollment. Inclusion criteria for healthy controls 1.No History of Malignancy: Individuals with no known history of any type of cancer. 2.No Severe Comorbidities: Participants should not have severe comorbid conditions that could influence study outcomes. 3.Clinically asymptomatic for lung cancer. 4.No CT and biopsy are required for enrollment in this cohort.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for lung cancer patients: 1. Pediatric Patients: Lung cancer patients aged below 18 years. 2. History of Other Cancers Any history of previous malignancies. 3. Prior or Ongoing Treatment: Patients who are currently on active therapy (chemotherapy, radiation) or have undergone surgery for lung cancer. 4. Patients with unavailable CT and biopsy reports will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
sensitivity, specificity, Precision Recall (PR) Curve, Area under the curve, negative predictive value, positive predictive valueTimepoint: At Baseline

Secondary

MeasureTime frame
To assess the consistency and reliability of VarSee s performance across multiple clinical centersTimepoint: End of the study;To compare VarSee s diagnostic accuracy with standard clinical methodologiesTimepoint: At Baseline;To identify potential challenges, limitations, and areas for optimization in real-world clinical settingsTimepoint: Every 3 months;To analyze the computational efficiency, error rates, and overall robustness of VarSee s algorithmic framework, ensuring reliable and scalable performance under varying clinical conditionsTimepoint: End of the study

Countries

India

Contacts

Public ContactDr Minit Shah

Tata Memorial Hospital, Mumbai

minitjshah@gmail.com7021620792

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026