Association Between Screening Behaviors and Lung Cancer Spectrum
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population consists of patients with pathologically confirmed primary lung cancer who are newly diagnosed within the past year at Fudan University Shanghai Cancer Center and participating multicenter sites. The population includes individuals across various age groups, smoking statuses, and risk profiles, who are capable of providing detailed medical history and pre-diagnosis screening records. Patients with recurrent lung cancer, metastatic disease, or those unable to complete the study questionnaires due to cognitive or mental health conditions are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Epidemiological Characteristics
Distribution of age, gender, smoking history, and pathological subtypes.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Curative Time Window Capture Rate
The proportion of tumors captured at the AIS/MIA or pure GGN stage
Time frame
through study completion, an average of 1 year2
Socioeconomic Indicators
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.
Time frame
through study completion, an average of 1 year3
Cumulative Radiation Dose
Time frame
through study completion, an average of 1 year4
Screening Efficacy
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov