Molecular Analysis and Treatment Options of SCLC

Recruiting

• Conditions: Small Cell Lung Carcinoma; Small Cell Lung Cancer Limited Stage; Small Cell Lung Cancer Extensive Stage; Small-cell Lung Cancer; Small Cell Lung Cancer, Combined Type

• Registration Number: NCT05945745
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.

Ongoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.

In summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Histologically proven diagnosis of SCLC
• 18 years of age or older
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Histologically proven diagnosis of non-SCLC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	20 years	Collect detailed clinical information on patients with SCLC via the electronic medical records
Progression-free survival (PFS)	20 years	Collect detailed clinical information on patients with SCLC via the electronic medical records
Disease control rate (DCR)	20 years	Collect detailed clinical information on patients with SCLC via the electronic medical records

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	20 years	Collect detailed clinical information on patients with SCLC via the electronic medical records

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China