Actively Recruiting

Age: 18Years +
All Genders
NCT07026669

A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-06-18

40

Participants Needed

1

Research Sites

152 weeks

Total Duration

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AI-Summary

What this Trial Is About

Lung cancer is one of the malignant tumors with the highest incidence and mortality rates globally, with small cell lung cancer (SCLC) accounting for approximately 15%. SCLC is characterized by high malignancy, propensity for metastasis and drug resistance, and a 5-year survival rate below 7%. Despite partial progress in chemotherapy and immunotherapy, SCLC patients generally have extremely poor prognosis, and there is a lack of precise therapeutic efficacy prediction and dynamic monitoring approaches. Existing biomarkers (such as TP53/RB1 mutations) are inadequate for clinical needs due to high heterogeneity and insufficient dynamic characteristics. The rapid development of multi-omics technologies provides new opportunities for analyzing SCLC molecular features; however, previous studies have predominantly focused on single omics approaches with insufficient systematic integration, limiting clinical translation. This study aims to systematically integrate multiple omics technologies to construct predictive and dynamic monitoring models for SCLC therapeutic efficacy, providing new methods and evidence for SCLC clinical treatment and dynamic monitoring.

CONDITIONS

Official Title

A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily signed informed consent
  • Age 18 years or older
  • Expected survival time of at least 3 months
  • ECOG performance status score of 0 or 1
  • Treatment-naive limited-stage or extensive-stage small cell lung cancer confirmed by histology or cytology
  • Agreement to provide blood and paraffin-embedded tissue samples
  • Presence of measurable target lesions for treatment efficacy evaluation
Not Eligible

You will not qualify if you...

  • Archived tumor tissue or biopsy showing non-small cell lung cancer or mixed small cell/non-small cell components
  • Unsuitable for peripheral blood collection due to complications or other reasons as determined by investigator
  • Active, known, or suspected autoimmune disease (except certain stable conditions)
  • Active tuberculosis infection or history of active pulmonary tuberculosis within the past year without effective treatment
  • Conditions requiring immunosuppressive drugs or corticosteroids at immunosuppressive doses
  • Pregnancy or lactation
  • Positive HIV antibody, active hepatitis B or C infection above detection limits
  • History of severe neurological or psychiatric disorders
  • Use of anti-tumor drugs before blood sample collection
  • Previous history of other malignant tumors except specified carcinoma in situ or non-melanoma skin cancer
  • Receipt of live vaccines within 28 days before blood sample collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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, 100021

Actively Recruiting

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Research Team

Z

Zhijie Wang, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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