NCT07070011Recruiting
Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies. A prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 38 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- Jan 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Shanghai Chest Hospital of Shanghai Jiao Tong University
- Diseases
- Lung cancer
- NCT number
- NCT07070011
What you commit to
- Study type: Observational
- Planned participants: 38
- From Jan 2023 to the primary completion date, Dec 2026
- 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.
Other illness
- Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy;
Other
- Patients whose pathological diagnosis does not meet the requirements;
- Patients whose ECOG staging does not meet the requirements;
- Patients with incomplete clinical sample information and follow-up information;
Who the study is looking for
- Requirements for patients enrolled in the project:
- The pathological diagnosis of the patient is ESSCLC;
- ECOG score 0 or 1；
- The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment;
- Patients with complete clinical sample information who meet the inclusion requirements
Age in the registry: 45 years to 80 years · 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 |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.