Molecular Analysis and Treatment Options of SCLC

NCT05945745 | Recruiting

• 1 other identifier: THORACIC004
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Objective response rate (ORR)

  Collect detailed clinical information on patients with SCLC via the electronic medical records

  20 years

• Disease control rate (DCR)

  Collect detailed clinical information on patients with SCLC via the electronic medical records

  20 years

• Progression-free survival (PFS)

  Collect detailed clinical information on patients with SCLC via the electronic medical records

  20 years

Secondary Outcomes (1)

• Overall survival (OS)

  20 years

Interventions

Chemotherapy DRUG

different treatments based on the molecular analysis

Also known as: immunotherapy, targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with SCLC are with the standard treatment and/or are enrolled in the clinical trials.

You may qualify if:

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

You may not qualify if:

• Histologically proven diagnosis of non-SCLC

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Central Study Contacts

Xiaomin Niu

CONTACT

021-22200000; ar_tey@hotmail.com, artey@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

CN (1)