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NCT Number: NCT07626177

Association Between Screening Behaviors and Lung Cancer 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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Chen Haiquan, MD

CONTACT

[email protected]

+86-21 64175590 ext. 1707

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Epidemiological Characteristics

    Time frame: through study completion, an average of 1 year

    Distribution of age, gender, smoking history, and pathological subtypes.

Secondary outcomes

  1. Curative Time Window Capture Rate

    Time frame: through study completion, an average of 1 year

    The proportion of tumors captured at the AIS/MIA or pure GGN stage

  2. Socioeconomic Indicators

    Time frame: 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.

  3. Cumulative Radiation Dose

    Time frame: through study completion, an average of 1 year

  4. Screening Efficacy

    Time frame: through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Multicenter, Prospective, Observational Study on the Association Between Real-World Lung Cancer Screening Behaviors and Lung Cancer Disease Spectrum

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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