CClinicalTrials.gg
RecruitingNCT05902559ALPINEUpdated Oct 15, 2024

Assessment of Novel Biomarkers in Participants Undergoing Targeted Lung Health Checks

An observational study in Lung Cancer, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to participants aged 55 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by University College, London · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
55 Years to 74 Years
Sex
All
01

Study summary

Low-dose CT (LDCT) screening for lung cancer (LCS) has been shown to reduce lung cancer specific mortality in multiple randomised controlled trials. However, although LDCT screening has been demonstrated to reduce cancer- specific mortality, there remain outstanding questions regarding how screening can be implemented. In particular, indeterminate nodules are common, and can be challenging to distinguish from benign nodules on CT appearances alone. Furthermore, distinguishing cancers which are likely to become clinically significant from those that will remain indolent is challenging, but essential to prevent over-treatment and overdiagnosis. There is significant interest in using a multi-modal approach to LCS, incorporating biomarkers obtained from minimally-invasive samples alongside LDCT to improve ability to recognise clinically-significant lung cancers at an early stage.

The Targeted Lung Health Check (TLHC) programme is an NHS programme with the aim of using LDCT screening in appropriately high-risk individuals to improve early diagnosis and survival in lung cancer. The North Central London TLHC programme started in December 2022.

The purpose of the ALPINE study is to develop a platform to allow collection of minimally-invasive samples from participants undergoing screening within the North Central London TLHC programme. The use of such biomarkers in the diagnosis of lung cancer is a rapidly developing field and novel techniques and technologies are continuously under development. The ALPINE study will generate a cohort with matched biosamples, CT scans and clinical data which will be uniquely well placed to serve to develop or validate biomarkers in lung cancer screening and risk prediction.

02

Conditions studied

  • Lung Cancer
03

In context

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 74 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Participants eligible for Low Dose CT scan screening in the North Central London Targeted Lung Health Check programme

Inclusion criteria

  • Attended one of more visits as part of the NCL NHS TLHC programme
  • Adults aged between 55 years and 74 years and 364 days
  • Have capacity and can provide written consent

Exclusion criteria

Exclusion Criteria:

  • Declines participation in ALPINE
  • Lacking capacity and unable to provide written consent
  • Patients who are considered by the clinician to be unfit/not suitable for enrolment in ALPINE
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To identify novel molecular, immune and clinical biomarkers to improve the sensitivity and specificity of lung cancer screening beyond what is achieved with conventional risk prediction models and low-dose CT scanning.

    This includes proteomics, metabolomics, genomics and immune repertoire characterization performed on peripheral bloods.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • University College London Hospitals NHS Foundation Trust
    London, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05902559
Lead sponsor
University College, London
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Aug 1, 2023
Primary completion
Nov 20, 2027 (estimated)
Completion
Nov 20, 2028 (estimated)
Last update
Oct 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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