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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Ratio of each molecular subtypes [Срок оценки: After registration of this study]

Вторичные конечные точки (1)

• Success rate of each molecular profiling methods [Срок оценки: After completion of registration]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

South Korea · 6 центров

• 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

Идентификаторы

NCT: NCT02688894 · 2016-02-071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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