- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945745
Molecular Analysis and Treatment Options of SCLC
Molecular Landscape Analysis and Clinical Implications for SCLC
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiaomin Niu
- Phone Number: 021-22200000
- Email: ar_tey@hotmail.com, artey@sjtu.edu.cn
Study Locations
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-
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Shanghai, China
- Recruiting
- Shanghai Chest Hospital
-
Contact:
- Xiaomin Niu
- Phone Number: 021-22200000
- Email: ar_tey@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 20 years
|
Collect detailed clinical information on patients with SCLC via the electronic medical records
|
20 years
|
Disease control rate (DCR)
Time Frame: 20 years
|
Collect detailed clinical information on patients with SCLC via the electronic medical records
|
20 years
|
Progression-free survival (PFS)
Time Frame: 20 years
|
Collect detailed clinical information on patients with SCLC via the electronic medical records
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 20 years
|
Collect detailed clinical information on patients with SCLC via the electronic medical records
|
20 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THORACIC004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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