Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Association Between Screening Behaviors and Lung Cancer Spectrum

30. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Lungekreft

Studietype

Observasjonsmessig

Registrering (Antatt)

5390

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fudan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. mai 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

30. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)