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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07626177
Enrollment
5390
Registered
2026-06-04
Start date
2026-05-14
Completion date
2027-06-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

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.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Epidemiological Characteristicsthrough study completion, an average of 1 yearDistribution of age, gender, smoking history, and pathological subtypes.

Secondary

MeasureTime frameDescription
Curative Time Window Capture Ratethrough study completion, an average of 1 yearThe proportion of tumors captured at the AIS/MIA or pure GGN stage
Socioeconomic Indicatorsthrough study completion, an average of 1 yearThis 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.
Cumulative Radiation Dosethrough study completion, an average of 1 year
Screening Efficacythrough study completion, an average of 1 yearThis 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026