NCT07626177

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,390

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
May 2026Jun 2027

Study Start

First participant enrolled

May 14, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 18, 2026

Last Update Submit

May 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Epidemiological Characteristics

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

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Curative Time Window Capture Rate

    through study completion, an average of 1 year

  • Socioeconomic Indicators

    through study completion, an average of 1 year

  • Cumulative Radiation Dose

    through study completion, an average of 1 year

  • Screening Efficacy

    through study completion, an average of 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief of Thoracic Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 4, 2026

Study Start

May 14, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations