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NCT Number: NCT06575439

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University College London Hospital

London, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  1. Participant outcomes such as cancer stage, treatment, mortality

    Time frame: Cancer stage at time of diagnosis, treatment and mortality through study completion (likely 5 years)

    From review of electronic health records

  2. Measurement of modifiable and non-modifiable factors associated with LCINS

    Time frame: Through study completion (likely 5 years)

    To be determined

Study contacts

Contact information is provided by the study sponsor or research team.

Neal Navani, PhD

CONTACT

[email protected]

020 7679 2000

Sindhu Naidu, MBBS

CONTACT

[email protected]

020 7679 2000

Sponsors and collaborators

Lead sponsor

University College London Hospitals

Other

Registry information

Acronym: OLIVE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 28, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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