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Age: 18Years +
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ID07026669

A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer: A Prospective, Non-interventional Study

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

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Small cell lung cancer (SCLC) is a highly malignant type of lung cancer with a low 5-year survival rate below 7%. It often spreads quickly and resists treatment, making prognosis poor. Researchers are exploring new ways to predict how well treatments will work and to monitor disease progress more effectively by integrating multiple molecular data types from blood and tissue samples. This approach aims to provide better tools for managing SCLC treatment and monitoring. The study collects blood and paraffin-embedded tissue samples from patients before and during treatment to analyze multiple molecular features using advanced sequencing technologies. Samples are taken before the first treatment cycle, before the third cycle, and at disease progression. Researchers will develop and test models that use these molecular data to predict treatment response and track disease changes over time. Participants provide demographic, clinical, imaging, laboratory, and tumor marker information. The study evaluates molecular subtypes and scoring models related to SCLC treatment effectiveness and monitors changes in blood molecular data during therapy. The monitoring period lasts up to 3 years or until disease progression. This observational study involves 40 patients and aims to support dynamic treatment decisions and improve understanding of SCLC molecular changes during therapy.

CONDITIONS

Brief 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...

  • Voluntary signing of informed consent
  • Age 18 years or older
  • Expected survival time of 3 months or more
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Treatment-nafve limited-stage or extensive-stage small cell lung cancer confirmed by histology or cytology
  • Agreement to provide blood samples and paraffin-embedded samples
  • Measurable target lesions for efficacy evaluation
Not Eligible

You will not qualify if you...

  • Archived tumor tissue or pre-treatment biopsy showing non-small cell or mixed tumor components
  • Unsuitability for blood collection due to complications or other conditions
  • Active or suspected autoimmune disease, except specific limited types
  • Active tuberculosis infection or history of pulmonary tuberculosis within the last year without adequate treatment
  • Use of immunosuppressive drugs or corticosteroids at immunosuppressive doses
  • Pregnancy or lactation
  • Positive HIV antibody or active hepatitis B or C infection above study thresholds
  • History of severe neurological or psychiatric disorders
  • Use of anti-tumor drugs before blood sample collection
  • Previous malignant tumors except certain non-melanoma skin cancers and specified carcinoma in situ
  • Receipt of live vaccines within 28 days before blood sample collection

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Before first-line treatment

Participants provide unstained paraffin tissue sections and baseline peripheral blood samples before starting first-line treatment to analyze molecular characteristics of small cell lung cancer.

1 visit (in-person)

Monitoring

Duration - Up to 3 years or until disease progression

Participants provide peripheral blood samples before the third treatment cycle and at disease progression to dynamically monitor treatment efficacy using multi-omics sequencing data.

3 visits (in-person) including before third cycle and at disease progression

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

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Research Team

Z

Zhijie Wang, MD

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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