Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05902559

Assessment of Novel Biomarkers in Participants Undergoing Targeted Lung Health Checks

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

55 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Location status: Recruiting

Location contact

Amyn Bhamani

CONTACT

[email protected]

Chuen Ryan Khaw

CONTACT

[email protected]

02034479005

Samuel Janes

PRINCIPAL_INVESTIGATOR

Who can participate

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

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

  • 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

Treatment and study plan

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.

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

Registry information

Acronym: ALPINE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 15, 2023
Registry last updated
Oct 15, 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.

Published trials that share one or more normalized conditions with this study.