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Clinical Trials/NCT06575439
NCT06575439
Recruiting
Not Applicable

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

University College London Hospitals1 site in 1 country225 target enrollmentSeptember 17, 2024
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
University College London Hospitals
Enrollment
225
Locations
1
Primary Endpoint
Demographics, comorbidities and environmental exposures of participants
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 17, 2024
End Date
September 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University College London Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Neal Navani

Professor of Respiratory Medicine

University College, London

Eligibility Criteria

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

Outcomes

Primary Outcomes

Demographics, comorbidities and environmental exposures of participants

Time Frame: 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

Time Frame: Presentation mode and symptoms at time of diagnosis (approximately up to 52 weeks prior to diagnosis)

From review of electronic health records

Secondary Outcomes

  • Participant outcomes such as cancer stage, treatment, mortality(Cancer stage at time of diagnosis, treatment and mortality through study completion (likely 5 years))
  • Measurement of modifiable and non-modifiable factors associated with LCINS(Through study completion (likely 5 years))

Study Sites (1)

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