NCT05368298

Brief Summary

The study will use a blood sample collected from participants to:

  • Develop new ways of finding and diagnosing lung health problems, such as lung cancer.
  • Develop tools which make it easier to screen people with possible lung health problems, diagnose problems earlier and with fewer tests, and start the best treatment faster.
  • Help improve the early diagnosis of lung cancer, as finding lung cancer early means that it can be treated more easily and successfully.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
872

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Aug 2022Sep 2027

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

5.1 years

First QC Date

May 5, 2022

Last Update Submit

May 20, 2026

Conditions

Lung Cancer

Keywords

screeninglung health checkartificial intelligencealgorithmdiagnosisdetectionbloodblood testearly detectionlunglung cancerlung screeningAIbiomarker

Outcome Measures

Primary Outcomes (1)

  • To develop an algorithm that gives a greater than chance improved ability to diagnose lung cancer using the blood biomarkers with or without the AI CT algorithm compared to not using them

    by 30Sep2027

Secondary Outcomes (1)

  • To develop an algorithm that gives a greater than chance improved ability to diagnose lung cancer using the blood biomarkers with or without the AI CT and blood markers algorithm compared to not using them

    by 30Sep2027

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been offered follow up appointments after their Lung Health Check. Patients may be invited to attend a Lung Health Check if they have ever smoked and are aged 55 - 75 years old.

You may qualify if:

  • Patients with a pulmonary nodule or nodule(s) detected on a CT scan performed as part of Lung Cancer Screening from the Lung Health Check centres, that require further investigation with a PET-CT scan, and / or biopsy, and / or resection
  • Willing and able to give informed consent

You may not qualify if:

  • None -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Lung Health Check: Oxford - Churchill Hospital, OUH

Oxford, Oxfordshire, United Kingdom

Location

Lung Health Check Centre: Royal Sussex

Brighton, United Kingdom

Location

Lung Health Check Centre: North Bristol

Bristol, United Kingdom

Location

Lung Health Check Centre: Gateshead

Gateshead, United Kingdom

Location

Lung Health Check Centre: Corby & Kettering

Kettering, United Kingdom

Location

Lung Health Check Centre: Cheshire & Merseyside

Liverpool, United Kingdom

Location

Lung Health Check Centre: RM Partners

London, United Kingdom

Location

Lung Health Check Centre: Newcastle & Gateshead

Newcastle, United Kingdom

Location

Lung Health Check Centre: Plymouth

Plymouth, United Kingdom

Location

Lung Health Check Centre: Stoke

Stoke, United Kingdom

Location

Lung Health Check Centre: South Tyneside and Sunderland

Sunderland, United Kingdom

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

30ml blood sample will be collected and processed, resulting in plasma and serum samples for analysis.

MeSH Terms

Conditions

Lung NeoplasmsDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Lee

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

August 11, 2022

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

GB(11)