- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200032
- Recrutement
- Fudan University Cancer Center
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Contact:
- Chen Haiquan, MD
- Numéro de téléphone: 1707 +86-21 64175590
- E-mail: hqchen1@yahoo.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Epidemiological Characteristics
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Curative Time Window Capture Rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ECTOP-1038
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