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Association Between Screening Behaviors and Lung Cancer Spectrum

30. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Lungekræft

Undersøgelsestype

Observationel

Tilmelding (Anslået)

5390

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Kina
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Kina, 200032
    - Rekruttering
    - Fudan University Cancer Center
    - Kontakt:
      
      Chen Haiquan, MD
      
      Telefonnummer: 1707 +86-21 64175590
      
      E-mail: hqchen1@yahoo.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Epidemiological Characteristics Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Curative Time Window Capture Rate Tidsramme: 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 Tidsramme: 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 Tidsramme: through study completion, an average of 1 year		through study completion, an average of 1 year
Screening Efficacy Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fudan University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)