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

NCT07026669 | Recruiting

• 1 other identifier: NCC5154
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• SCLC scoring models and molecular subtypes

  To establish and validate SCLC therapeutic efficacy prediction and dynamic monitoring models based on multi-omics detection, and construct SCLC scoring models and molecular subtypes.

  From enrollment to the end of monitoring at 3 years or the occurrence of disease progression.

Secondary Outcomes (2)

• Sensitivity and specificity of SCLC therapeutic efficacy prediction and dynamic monitoring models

  From enrollment to the end of monitoring at 3 years or the occurrence of disease progression.

• Dynamic changes in peripheral blood multi-omics data during SCLC treatment efficacy processes

  From enrollment to the end of monitoring at 3 years or the occurrence of disease progression.

Study Arms (1)

Limited-stage/Extensive-stage small cell lung cancer

Small cell lung cancer with lymph node metastasis/distant metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SCLC patients From Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

You may qualify if:

• Patients meeting the following criteria may have samples collected:
• Voluntary signing of informed consent;
• Age ≥18 years;
• Expected survival time ≥3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Treatment-naïve limited-stage or extensive-stage SCLC confirmed by histology or cytology;
• Agreement to provide blood samples and paraffin-embedded samples;
• Measurable target lesions for efficacy evaluation.

You may not qualify if:

• Patients with any of the following conditions will be excluded from sample collection:
• 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;
• Investigator-determined unsuitability for peripheral blood collection due to complications or other conditions;
• 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);
• 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;
• Comorbidities requiring immunosuppressive drug treatment, or requiring systemic or local corticosteroid use at immunosuppressive doses;
• Pregnancy or lactation;
• 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);
• History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
• Use of any anti-tumor drugs before blood sample collection;
• 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);
• Patients receiving live vaccines within 28 days before blood sample collection.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (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, 100021, China

RECRUITING

Related Publications (12)

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  PMID: 36252600 BACKGROUND

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• Heeke S, Gay CM, Estecio MR, Tran H, Morris BB, Zhang B, Tang X, Raso MG, Rocha P, Lai S, Arriola E, Hofman P, Hofman V, Kopparapu P, Lovly CM, Concannon K, De Sousa LG, Lewis WE, Kondo K, Hu X, Tanimoto A, Vokes NI, Nilsson MB, Stewart A, Jansen M, Horvath I, Gaga M, Panagoulias V, Raviv Y, Frumkin D, Wasserstrom A, Shuali A, Schnabel CA, Xi Y, Diao L, Wang Q, Zhang J, Van Loo P, Wang J, Wistuba II, Byers LA, Heymach JV. Tumor- and circulating-free DNA methylation identifies clinically relevant small cell lung cancer subtypes. Cancer Cell. 2024 Feb 12;42(2):225-237.e5. doi: 10.1016/j.ccell.2024.01.001. Epub 2024 Jan 25.

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MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhijie Wang, MD

CONTACT

+8613466323860; jie_969@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)