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Diagnostic utility of circulating tumour cells and cell-free DNA in lung cancer patients with mediastinal/hilar lymphadenopathy

Diagnostic utility of circulating tumour cells and cell-free DNA (liquid biopsy) in lung cancer patients with mediastinal/hilar lymphadenopathy on endobronchial ultrasound-transbronchial needle aspiration: A multicentric diagnostic accuracy study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/090655
Enrollment
140
Registered
2025-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: C34- Malignant neoplasm of bronchus andlung

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Nilotpal Chowdhury
Lead Sponsor
Dr Brijnandan Gupta
Collaborator
Dr Mayank Mishra
Collaborator
Dr Subodh Kumar Pandey
Collaborator
MRU AIIMS Rishikesh
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with clinico-radiologically suspected lung cancer with mediastinal/hilar lymph nodes will be enrolled.

Exclusion criteria

Exclusion criteria: a) Denial of consent to participate b) History of a prior malignancy within five years of enrollment in the present study

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of Circulating tumor cells in detecting lung cancer in patients with mediastinal/hilar lymphadenopathy undergoing EBUS guided FNA. The fine-needle aspiration biopsy report from the EBUS will serve as the reference standard.Timepoint: Within 4 days of a adequate EBUS FNAB—

Secondary

MeasureTime frame
To evaluate the sensitivity and specificity of CTCs in lung cancer patients with inadequate or indeterminate EBUS-TBNA cytology on the first attempt at EBUS-guided FNA. Fine needle aspiration biopsy from subsequent attempts as well as a combination of CT or MRI findings, ancillary tissue diagnosis by FNA or biopsy from a separate secondary lymph node, tissue or pleural fluid will serve as reference test.Timepoint: Within 4 days of first EBUS guided FNA.;Evaluate the correlation of CTC yield with disease stageTimepoint: Within 4 days of first EBUS guided FNA;Extract the cell free DNA from plasma and tissue DNA from tumor cells for detection of molecular markersTimepoint: Within 4 days of adequate EBUS guided FNA;Comparison of EGFR and common targetable mutations status from DNA extracted from cell free DNA to that extracted from tissue FNAB.Timepoint: As a batch after completion of all EBUS guided FNA—

Countries

India

Contacts

Public ContactNilotpal Chowdhury

All India Institute of Medical Sciences, Rishikesh

nilotpal.chowdhury@gmail.com8475000264

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026