The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]

Study Overview
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Brief Summary
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This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial. This procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood. Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue. Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH. Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

Official Title
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The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]

Conditions
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Small Cell Lung Cancers

Intervention / Treatment
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* Other: No treatment is included in this protocol.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of fully informed consent prior to any study specific procedures. Patients must be ≥20 years of age. Histologically or cytologically confirmed Small cell lung cancers ECOG performance status of 0 to 2 Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis Exclusion Criteria: More than two prior chemotherapy regimen for the treatment of small cell lung cancer Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method) Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤2 years.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Small cell lung cancers<br>To provide molecular characteristics of Small cell lung cancers to proceed SUKSES trial, To assess success rate of molecular profiling of Small cell lung cancers | Other: No treatment is included in this protocol.<br>* Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH. Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of each molecular subtypes |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of each molecular profiling methods |  | 24 months |