The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No treatment is included in this protocol..
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancers, Neuroendocrine Carcinoma. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other No treatment is included in this protocol.
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.
Primary outcome measures
- Ratio of each molecular subtypes [Time frame: After registration of this study]
Secondary outcome measures (1)
- Success rate of each molecular profiling methods [Time frame: After completion of registration]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
South Korea · 6 centers
- Gachon University Gil Medical Center — Incheon
- Seoul National University Bundang Hospital — Seongnam
- Samsung Medical Center — Seoul
- VHS Medical Center — Seoul
- Chungbuk University Hospital — Taebuk
- Ulsan University Hospital — Ulsan
Identifiers
NCT: NCT02688894 · 2016-02-071