Using targeted bronchial washing to test for genetic changes in early-stage lung cancer
Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients With Early-stage Non-small Cell Lung Cancer
This study is testing a new way to check for genetic changes in early-stage lung cancer using a special washing technique during a lung procedure to help doctors make better treatment decisions for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Pusan National University Hospital Academic / other |
| Locations | 1 site (Busan) |
| Trial ID | NCT06301295 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of using ultrathin bronchoscopy to perform intratumoral washing for detecting genetic alterations in patients suspected of having early-stage lung cancer. The study is a single-arm, open-label design that focuses on patients who are planning to undergo surgery and are opting for genetic testing through liquid biopsy. By utilizing Next Generation Sequencing, the trial aims to improve the accuracy of lung cancer diagnosis and treatment planning.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older who are suspected of having resectable lung cancer and are planning to undergo surgery.
Not a fit: Patients with other types of lung cancer or benign lung lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the detection of genetic alterations in early-stage lung cancer, leading to more personalized treatment options.
How similar studies have performed: While this approach is innovative, similar studies using liquid biopsy and genetic testing have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
1. Inclusion Criteria: * Age ≥ 20 years * Obtained written informed consent * Subjects suspected of having resectable lung cancer on computed tomography * Subjects without contraindication to brochoscopy * Subjects planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using Next Generation Sequencing 2. 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
Where this trial is running
Busan
- Pusan National University Hospital — Busan, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jung-Seop Eom, MD, PhD — Pusan National University Hospital
- Study coordinator: Jung-Seop Eom, MD, PhD
- Email: ejspulm@gmail.com
- Phone: 82-51-240-7889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.