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

NCT06575439 | Recruiting

• 1 other identifier: 159292
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Demographics, comorbidities and environmental exposures of participants

  From review of electronic health records

  Comorbidities and environmental exposures at diagnosis (approximately up to 156 weeks prior to diagnosis)

• Participant pathways including presentation mode and symptoms

  From review of electronic health records

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

Secondary Outcomes (2)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will aim to recruit participants who have been diagnosed or treated with primary lung cancer at any participating study site.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

University College London Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Neal Navani, PhD

CONTACT

020 7679 2000; n.navani@ucl.ac.uk

Sindhu Naidu, MBBS

CONTACT

020 7679 2000; s.naidu@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)