- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03425825
Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona, España, 08025
- Local Institution
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London, Reino Unido, N19JY
- Local Institution
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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:
Cohort 1 and 2:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Cohort 3:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC not earlier than October 2013
- Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Exclusion Criteria:
- Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
Other Inclusion/Exclusion criteria may apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
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ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
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relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Distribution of Patient Demographic Characteristics
Periodo de tiempo: At baseline
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Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors |
At baseline
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Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Periodo de tiempo: At baseline
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Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
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Distribution of Patient Clinical Characteristics in patients with LD-SCLC
Periodo de tiempo: At baseline
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Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
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Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Periodo de tiempo: At baseline
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Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
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Distribution of treatment patterns in patients with ED-SCLC
Periodo de tiempo: Approximately 44 months
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Details on patients prior treatment Patterns will be summarized using descriptive statistics
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Approximately 44 months
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Distribution of treatment patterns in patients with LD-SCLC
Periodo de tiempo: Approximately 44 months
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Details on patients prior treatment Patterns will be summarized using descriptive statistics
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Approximately 44 months
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Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
Periodo de tiempo: Approximately 44 months
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Details on patients prior treatment Patterns will be summarized using descriptive statistics
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Approximately 44 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Composite of SCLC-related healthcare resource utilization (HCRU)
Periodo de tiempo: Approximately 44 months
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HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
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Approximately 44 months
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Overall survival (OS)
Periodo de tiempo: Approximately 44 months
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Approximately 44 months
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Progression-free survival (PFS)
Periodo de tiempo: Approximately 44 months
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Approximately 44 months
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Objective response rate (ORR)
Periodo de tiempo: Approximately 44 months
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Approximately 44 months
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Mortality rate
Periodo de tiempo: Approximately 44 months
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Approximately 44 months
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Treatment-related adverse events (AEs) leading to discontinuation
Periodo de tiempo: Approximately 44 months
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Approximately 44 months
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Incidence of surgery as cancer-directed therapy
Periodo de tiempo: Approximately 44 months
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To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Incidence of radiation therapy as cancer-directed therapy
Periodo de tiempo: Approximately 44 months
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To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Incidence of best supportive care (BSC)
Periodo de tiempo: Approximately 44 months
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To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Incidence of palliative care
Periodo de tiempo: Approximately 44 months
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To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CA209-913
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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