Association Between Screening Behaviors and Lung Cancer Spectrum

May 30, 2026 updated by: Haiquan Chen, Fudan University

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.

Study Overview

Status

Recruiting

Conditions

Lung Cancer

Study Type

Observational

Enrollment (Estimated)

5390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200032
    - Recruiting
    - Fudan University Cancer Center
    - Contact:
      
      Chen Haiquan, MD
      
      Phone Number: 1707 +86-21 64175590
      
      Email: hqchen1@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiological Characteristics Time Frame: through study completion, an average of 1 year	Distribution of age, gender, smoking history, and pathological subtypes.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year
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.	through study completion, an average of 1 year
Cumulative Radiation Dose Time Frame: through study completion, an average of 1 year		through study completion, an average of 1 year
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.	through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)