NCT07331701Not yet recruiting
Association of BAL Fluid T-Cell Immune Activity With Tumor PD-L1 Expression and Its Prognostic Value: A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
This prospective observational study aims to evaluate whether immune profiles of T-cell subsets in bronchoalveolar lavage fluid can complement tumor PD-L1 expression, assessed by immunohistochemistry in tumor tissue specimens, in predicting clinical outcomes in patients with advanced lung cancer. Although tumor PD-L1 expression measured on tissue biopsies is widely used to guide immunotherapy decisions, its predictive value is limited by spatial heterogeneity and sampling variability. By analyzing activated, exhausted, and regulatory T-cell populations in bronchoalveolar lavage fluid and examining their association with tissue-based tumor PD-L1 expression, this study seeks to determine whether combining local immune biomarkers with PD-L1 expression improves the prediction of treatment response and survival in patients receiving standard-of-care systemic therapy.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 29 Dec 2025
- Start date
- Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07331701
What you commit to
- Study type: Observational
- Planned participants: 60
- From Jan 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of treatment for acute lower respiratory tract infection (including pneumonia or fungal infection) within 4 weeks prior to bronchoscopy
- Current use of systemic immunosuppressive therapy
- Patients with recurrent stage IV lung cancer after prior definitive therapy
Other illness
- History of solid organ transplantation or hematopoietic stem cell transplantation
- Known autoimmune disease requiring systemic immunosuppressive treatment
Other
- Current or planned use of biologic immunomodulatory agents
- Pregnant women
Who the study is looking for
- Adults aged 19 years or older
- Patients with suspected or histologically confirmed stage IV lung cancer based on clinical and radiologic findings
- Scheduled to undergo clinically indicated bronchoscopy with bronchoalveolar lavage as part of routine clinical care
- Able and willing to provide written informed consent
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SMG-SNU Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.