Lung CancerOLIVENCT06575439
An Observational Study of Predictors and Outcomes of Lung Cancer in Never-smokers in the UK
An observational study of Lung Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 225 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2024to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will aim to recruit participants who have been diagnosed or treated with primary lung cancer at any participating study site.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
About this study
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
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics, comorbidities and environmental exposures of participants
From review of electronic health records
Measured: 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
Measured: 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
From review of electronic health records
Measured: 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
To be determined
Measured: Through study completion (likely 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start17 Sep 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Navani, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575439
- Sponsor's protocol ID
- 159292
- Acronym
- OLIVE
- Status last verified
- Dec 2024
- First submitted
- 21 Aug 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available to non-study researchers (as per current ethics approval).
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Predictors and Outcomes of Lung Cancer in Never-smokers in the UK
- ClinicalTrials.gov ID
- NCT06575439
- Acronym / sponsor ID
- OLIVE / 159292
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will aim to recruit participants who have been diagnosed or treated with primary lung cancer at any participating study site.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Participants who have ever smoked cigarettes or tobacco will be excluded; this is defined as:
- For prospective participants, those who cannot consent will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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)
Measurement of modifiable and non-modifiable factors associated with LCINS
Time frame: Through study completion (likely 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No. No individual participant data will be made available to non-study researchers (as per current ethics approval).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neal Navani, PhD (020 7679 2000, n.navani@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics, comorbidities and environmental exposures of participants (time frame: Comorbidities and environmental exposures at diagnosis (approximately up to 156 weeks prior to diagnosis)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.