Molecular Analysis and Treatment Options of SCLC

Sponsor

Shanghai Chest Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05945745

Collaborator

(none)

500

Enrollment

Location

156

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Chemotherapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Molecular Landscape Analysis and Clinical Implications for SCLC

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2028

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) [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
Progression-free survival (PFS) [20 years]
Collect detailed clinical information on patients with SCLC via the electronic medical records

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Chest Hospital	Shanghai		China

Sponsors and Collaborators

Shanghai Chest Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaomin Niu, Principal Investigator, Shanghai Chest Hospital

ClinicalTrials.gov Identifier:

NCT05945745

Other Study ID Numbers:

THORACIC004

First Posted:

Jul 14, 2023

Last Update Posted:

Jul 14, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Immunomodulating Agents

Study Results

No Results Posted as of Jul 14, 2023