An Observational Study of Predictors and Outcomes of Lung Cancer in Never-smokers in the UK

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06575439
• Lead Sponsor: University College London Hospitals

Brief Summary

The goal of this observational study is to improve the early detection of lung cancer in adults who have smoked less than 100 tobacco cigarettes ("never-smokers") in the United Kingdom. The main questions it aims to answer are:

* To describe characteristics such as demographics, co-morbidities and environmental exposures

* To describe participant pathways including presentation mode and symptoms to understand if earlier diagnosis would be possible

* To describe participant outcomes such as cancer stage, treatment and mortality

* To quantitatively or qualitatively measure modifiable and non-modifiable factors that may be associated with LCINS including environmental measures, blood tests and genomic data.

Participants will currently have no change to their usual care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-28
• Study Start: 2024-09-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12
• Primary Completion: 2029-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• All adult participants from age of 18 who are diagnosed or treated with primary lung cancer through radiology or histology at any participating study site

Exclusion Criteria

• Participants who have ever smoked cigarettes or tobacco will be excluded; this is defined as:

  • More than 100 cigarettes or 75g tobacco in their lifetime
  • Those who have received a prescription for nicotine replacement therapy

• For prospective participants, those who cannot consent will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographics, comorbidities and environmental exposures of participants	Comorbidities and environmental exposures at diagnosis (approximately up to 156 weeks prior to diagnosis)	From review of electronic health records
Participant pathways including presentation mode and symptoms	Presentation mode and symptoms at time of diagnosis (approximately up to 52 weeks prior to diagnosis)	From review of electronic health records

Secondary Outcome Measures

Name	Time	Method
Participant outcomes such as cancer stage, treatment, mortality	Cancer stage at time of diagnosis, treatment and mortality through study completion (likely 5 years)	From review of electronic health records
Measurement of modifiable and non-modifiable factors associated with LCINS	Through study completion (likely 5 years)	To be determined

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom