Molecular Profiling in Small Cell Lung Cancer (MPSCLC)
Prospective Molecular Profiling in Small Cell Lung Cancer
Descripción general del estudio
Estado
Descripción detallada
Small cell lung cancer (SCLC) is most invasive subtypes of lung cancer. After diagnosis, the SCLC patients without treatment often die in 2-4 months. SCLC is a highly heterogeneous malignant tumor, the previous treatment principle of the tumor is based on the traditional histopathology, which not provide accurate guidance for precise treatment. In recent years, breakthrough has been made in molecular classification of breast cancer, non-small cell lung cancer, gastrointestinal cancer and of the other tumor, but SCLC molecular classification has not yet reported.
In this prospective study, SCLC tissues and blood samples from extensive SCLC patients will be obtained and evaluated of molecular profiling. Eligible population includes: patients who have not undergone any treatment and diagnosed of extensive SCLC by immunohistochemistry(IHC). The purpose is to evaluate molecular profiling of SCLC patients who are sensitive or resistant to chemotherapy (Cisplatin+Etoposide). To compare molecular alterations of SCLC patients with different prognosis (Overall Survival, Progress Free Survival).
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangzhou, Porcelana, 510282
- Reclutamiento
- Zhujiang Hospital
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Contacto:
- Qiongyao Wang
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Investigador principal:
- Linlang Guo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age: between 18 and 75 years old.
- Sexes Eligible for Study: All
- Diagnosed of SCLC by IHC, and divided into extensive stage.
- The ECOG (Eastern Cooperative Oncology Group, ECOG) PS(performance status，PS) Scale score is 0 or 1.
- At least one measurable lesions by CT scan.
- Expect to survive for at least three months.
- Peripheral blood routine and liver and kidney function meet the following criterion (blood draw 7 days before the treatment begins) :
- The White Blood Cell (WBC) is greater than the 3.0×10^9/L or neutrophils (ANC) more than 1.5 x10^9/L;
- Hemoglobin (HGB) is greater than 80 g/L.
- Platelet (PLT) is greater than 100×10^9/L.
- (AST/ALT): Aspartate aminotransferase/Alanine aminotransferase<3.0 times of normal range.
- Total bilirubin (TBIL) < 1.5 times of normal range.
- Creatinine (CREAT) < 1.5 times of normal range.
- Female or male patients must adopt effective birth control measures.
- Informed consent forms provided. Patients must meet each of the above criteria.
Exclusion Criteria:
- Other pathological types of tumors ,rather than small cell lung cancer.
- Incorporating other tumors in the early diagnosis;
- Patients who have received chemotherapy, radiotherapy or any other anti-cancer treatment.
- Patients that known to be allergic to the drug components involved in the study;
- Patients with severe allergies or allergies;
- Pregnant or breastfeeding women;
- Patients with acute infection which is difficult to control;
- Drug abuse, substance abuse, long-term alcohol and AIDS(Acquired Immune Deficiency Syndrome) patients.
Candidates who meet each of the exclusion criteria will not included in the research.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall survival(OS)
Periodo de tiempo: Five years
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OS is defined as time duration from randomization until the date of death from any cause.
If the participants who had survived after the end of the study, or loss of follow-up, their last time of contact is defined as a deadline.
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Five years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression-free survival (PFS)
Periodo de tiempo: Five years
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PFS is defined as time duration from randomization until the date of SD(Stable Disease) or PD(Progressed Disease) evaluated by WHO RECIST (World Health Organization Response Evaluation Criteria in Solid Tumors， Edition1.1).
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Five years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Linlang Guo, ZhuJiang Hostipal
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2017-BLK-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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