Prospective Observational Study on ES-SCLC

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07173946
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Anti-tumor Therapy — OTHER
    This is an observational cohort study. There is no intervention assigned by the study protocol. Treatment strategies (including but not limited to chemotherapy, immunotherapy, radiotherapy, and local interventional therapy) are determined solely by the treating physician based on clinical practice guidelines and individual patient circumstances.Patients will receive real-world anti-tumor treatments as prescribed by their physicians. Common treatments for extensive-stage small cell lung cancer (ES-SCLC) may include platinum-etoposide chemotherapy, immune checkpoint inhibitors (such as anti-PD-L1/PD-1 antibodies), radiotherapy, and other therapies per standard clinical practice. The study will observe and record these treatments and their outcomes.

Study Details

Study Title: A Real-World Study on Extensive-Stage Small Cell Lung Cancer (ES-SCLC) What is this study about? This research aims to learn more about how patients with extensive-stage small cell lung cancer (ES-SCLC) are treated in real-world hospital settings and how they respond to those treatments. While new drugs like immunotherapies have shown promise in clinical trials, this study will observe their effectiveness and safety in everyday practice. The goal is to improve future treatment strategies for everyone with this disease. What will I need to do if I join? This is an observational study. This means your doctors will decide your treatment plan as they normally would. The research team will not assign you any new or experimental treatments. You will be asked to allow the researchers to collect information from your medical records about your diagnosis, treatment, and health status. You will need to agree to regular follow-up visits (about every 3 months) by phone or clinic visit so we can track your health over time. Optional Part: You may choose to provide extra blood and tissue samples (often taken during your routine care) for deeper laboratory research. Scientists will use these samples to try to grow "mini-tumors" (organoids) in the lab to study the disease and test drug responses. You can still participate in the main study even if you decline this part. What are the benefits? You will receive more structured and consistent follow-up care. If you participate in the optional sample collection, you will receive a 100 RMB subsidy and a personal report on how your mini-tumor reacted to different drugs (this is for informational purposes only and not to guide your treatment). Your participation will help doctors better understand ES-SCLC and improve care for future patients. What are the risks or inconveniences? The main inconvenience is the time needed for follow-up visits. If you choose to provide tissue samples, the biopsy procedure itself carries standard risks (like pain, bleeding, or infection), which your doctor will manage carefully. Your participation is completely voluntary. You can leave the study at any time without giving a reason, and it will not affect your relationship with your doctors or the quality of your medical care.

Key Dates

First listed
Sep 15, 2025
Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
96 participants (estimated)

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 100 months. ]

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