- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07626177
Association Between Screening Behaviors and Lung Cancer Spectrum
A Multicenter, Prospective, Observational Study on the Association Between Real-World Lung Cancer Screening Behaviors and Lung Cancer Disease Spectrum
The goal of this observational study is to describe the clinical epidemiological characteristics and disease spectrum distribution of newly diagnosed primary lung cancer patients in a real-world setting. The main questions it aims to answer are:
What is the current status of lung cancer epidemiology, including age, gender, smoking history, and pathological subtype distribution? How do different lung cancer screening behaviors (e.g., overscreening, underscreening, guideline-concordant, and precision screening) influence the capture rate of the "curative time window" (defined as adenocarcinoma in situ (AIS)/minimally invasive adenocarcinoma (MIA) or pure Ground-Glass Nodules (GGNs) stage)? What are the economic costs and cumulative radiation exposure associated with these different screening patterns? Researchers will compare these screening behavior groups to evaluate the efficacy of the "low-age, low-frequency" screening strategy in capturing early-stage lung cancer.
Participants will be asked to:
Provide their medical history and detailed records of pre-diagnosis lung cancer screening (including CT scan history).
Allow researchers to collect and analyze their clinical, pathological, and radiological data from hospital records and medical databases.
Complete a questionnaire regarding their screening history and health-related behaviors.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Reclutamiento
- Fudan University Cancer Center
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Contacto:
- Chen Haiquan, MD
- Número de teléfono: 1707 +86-21 64175590
- Correo electrónico: hqchen1@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Histologically confirmed primary lung cancer within the past year (surgical or biopsy pathology).
- Patients capable of clearly recalling or providing medical and physical examination history prior to diagnosis.
Exclusion Criteria:
- Recurrent lung cancer or metastatic lung tumors.
- Severe lack of critical clinical data (e.g., inability to provide pathological type or stage).
- Patients with cognitive impairment or severe mental illness who cannot cooperate with the questionnaire.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Epidemiological Characteristics
Periodo de tiempo: through study completion, an average of 1 year
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Distribution of age, gender, smoking history, and pathological subtypes.
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through study completion, an average of 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Curative Time Window Capture Rate
Periodo de tiempo: through study completion, an average of 1 year
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The proportion of tumors captured at the AIS/MIA or pure GGN stage
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through study completion, an average of 1 year
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Socioeconomic Indicators
Periodo de tiempo: through study completion, an average of 1 year
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This measure assesses the total direct medical costs.
Data are collected through a combination of hospital electronic medical records (EMR) and a structured patient questionnaire.
Costs include pre-diagnosis examination expenses (e.g., CT scans, consultations) and post-diagnosis treatment expenses (e.g., surgery, hospitalization, systemic therapy), calculated based on standardized clinical billing data.
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through study completion, an average of 1 year
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Cumulative Radiation Dose
Periodo de tiempo: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Screening Efficacy
Periodo de tiempo: through study completion, an average of 1 year
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This measure evaluates the efficacy of screening behaviors in detecting early-stage lung cancer.
Data are derived from hospital clinical databases and a structured patient questionnaire.
Key parameters include the frequency of pre-diagnosis CT scans, age at first screening, and pathological stage at diagnosis.
The association is assessed using correlation analysis and logistic regression models to compare the capture rate of the "curative time window" (AIS/MIA/pure GGN) across different screening groups.
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- ECTOP-1038
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. .