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Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer

P

Pusan National University

Status

Completed

Conditions

Lung Cancer

Treatments

Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing

Study type

Interventional

Funder types

Other

Identifiers

NCT06141005
2310-011-132

Details and patient eligibility

About

This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

Full description

This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients with NSCLC.

Enrollment

65 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 20 years
  • Obtained written informed consent
  • No contraindication to bronchoscopy
  • Subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
  • Subjects planning to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing

Exclusion criteria

  • Subjects who withdraw informed consent
  • Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement
  • Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion
  • Subjects diagnosed with a benign lesion from the lung tissue lesion

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

65 participants in 1 patient group

Ultrathin bronchoscopy with intratumoral washing
Experimental group
Description:
Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing.
Treatment:
Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing

Trial contacts and locations

1

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Central trial contact

Soo Han Kim, MD, PhD; Jung-Seop Eom, MD, PhD

Data sourced from clinicaltrials.gov

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