- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200032
- Rekrutacyjny
- Fudan University Cancer Center
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Kontakt:
- Chen Haiquan, MD
- Numer telefonu: 1707 +86-21 64175590
- E-mail: hqchen1@yahoo.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Epidemiological Characteristics
Ramy czasowe: through study completion, an average of 1 year
|
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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Curative Time Window Capture Rate
Ramy czasowe: through study completion, an average of 1 year
|
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
Ramy czasowe: through study completion, an average of 1 year
|
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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ECTOP-1038
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