Neuroendocrine Carcinoma, Small Cell Lung Cancers
Conditions
Brief summary
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.
Detailed description
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 (molecular profiling) can be performed before, during, or after the initial 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. In addition, blood collection will be conducted at Baseline (initial), three weeks, six weeks, twelve weeks, and subsequent imaging. 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.
Interventions
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.
Sponsors
Samsung Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of fully informed consent prior to any study specific procedures. 2. Patients must be ≥20 years of age. 3. Histologically or cytologically confirmed Small cell lung cancers 4. ECOG performance status of 0 to 2 5. Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment 6. Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis
Exclusion criteria
1. More than two prior chemotherapy regimen for the treatment of small cell lung cancer 2. Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method) 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of each molecular subtypes | After registration of this study | To provide molecular characteristics of SCLC to proceed SUKSES trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of each molecular profiling methods | After completion of registration | To provide molecular characteristics of SCLC to proceed SUKSES trial |
Countries
South Korea
Contacts
CONTACTSe-Hoon Lee, MD,Ph.D.
CONTACTSeoha Kim
PRINCIPAL_INVESTIGATORSe-Hoon Lee, MD, PhD
Samsung Medical Center
Outcome results
None listed