Multi-omics blood and tissue testing to predict and monitor treatment response in small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center study will collect peripheral blood and paraffin-embedded tumor samples from treatment-naïve patients with limited- or extensive-stage small cell lung cancer before first-line therapy. Investigators will perform multi-omics sequencing on blood and tissue samples and analyze dynamic molecular changes in blood during treatment. They will use those data to build and validate predictive models and scoring systems for treatment efficacy and to define molecular subtypes. Secondary and exploratory analyses will examine model sensitivity/specificity across stages and search for candidate biomarkers and therapeutic targets.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients meeting the following criteria may have samples collected:

  1. Voluntary signing of informed consent;
  2. Age ≥18 years;
  3. Expected survival time ≥3 months;
  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  5. Treatment-naïve limited-stage or extensive-stage SCLC confirmed by histology or cytology;
  6. Agreement to provide blood samples and paraffin-embedded samples;
  7. Measurable target lesions for efficacy evaluation.

Exclusion Criteria:

* Patients with any of the following conditions will be excluded from sample collection:

  1. Archived tumor tissue or pre-treatment tumor biopsy or histological examination showing previous histological or cytological evidence of non-small cell or small cell/non-small cell mixed components;
  2. Investigator-determined unsuitability for peripheral blood collection due to complications or other conditions;
  3. Active, known, or suspected autoimmune disease (excluding vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to recur without external stimulation);
  4. Active tuberculosis (TB) infection based on chest X-ray, sputum examination, and clinical examination. Patients with active pulmonary TB infection history within the previous year should be excluded even if treated. Patients with active pulmonary TB infection history more than one year ago should also be excluded unless previous anti-TB treatment can be proven adequately effective;
  5. Comorbidities requiring immunosuppressive drug treatment, or requiring systemic or local corticosteroid use at immunosuppressive doses;
  6. Pregnancy or lactation;
  7. Positive human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBsAg positive and HBV-DNA \>10³ copies/ml), or hepatitis C virus infection (HCV antibody positive and HCV-RNA \> lower limit of detection at study center);
  8. History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
  9. Use of any anti-tumor drugs before blood sample collection;
  10. Previous history of other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast cancer);
  11. Patients receiving live vaccines within 28 days before blood sample collection.

Where it's running

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhijie Wang, MD
• Email: jie_969@163.com
• Phone: +8613466323860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.