Last reviewed · How we verify
NCT06192303
Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia
trial testing Bronchoalveolar lavage and pathogen metagenomic sequencing in Immune Checkpoint Inhibitor Associated Pneumonia in 104 participants. Status unknown.
1 May 2025
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 104 |
| Start date | 1 January 2023 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Bronchoalveolar lavage and pathogen metagenomic sequencing
Conditions studied
- Immune Checkpoint Inhibitor Associated Pneumonia — all drugs for Immune Checkpoint Inhibitor Associated Pneumonia →
Sponsor
Nanfang Hospital, Southern Medical University
Who can join
Adults 18 to 75, any sex, with Immune Checkpoint Inhibitor Associated Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer progression. Currently, there is a lack of diagnostic gold standards, which belongs to exclusive diagnosis. Empirical diagnosis and treatment in clinical practice can easily lead to the abuse of hormones and antibiotics, and even misdiagnosis and mistreatment, resulting in patient death. Therefore, early identification of CIP and pulmonary infection is the key to successful diagnosis and treatment. The CIP diagnosis and treatment guidelines recommend performing bronchoalveolar lavage as appropriate, but there is still a lack of large-scale prospective clinical studies. The beneficial pathogen metagenomic sequencing technology for the diagnosis of pulmonary infections has not been mentioned. Our research group conducted a prospective clinical study for the first time to evaluate the effectiveness and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in diagnosing CIP, explore biomarkers for diagnosing CIP, in order to improve the early diagnosis rate and treatment efficiency of CIP, and reduce the abuse of antibiotics and hormones.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Metagenomic next-generation sequencing unraveled the characteristic of lung microbiota in patients with checkpoint inhibitor pneumonitis: results from a prospective cohort study.
Zhou Z, Lin JR, Li J, Huang X, et al · · 2025 · cited 1× · PMID 41161821 · DOI 10.1136/jitc-2025-012444
Verify or expand the search:
- PubMed search for NCT06192303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
- NCT07091994 — A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy · Phase 4 · not yet recruiting
- NCT06444022 — hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation · Phase 1 · withdrawn
- NCT07537777 — Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted T · Phase 2 · not yet recruiting
- NCT07481032 — Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients · NA · not yet recruiting
- NCT07511894 — Beta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06192303 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanfang Hospital, Southern Medical University
- Last refreshed: 5 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06192303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing