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Trial Title:
Assessment of Novel Biomarkers in Participants Undergoing Targeted Lung Health Checks
NCT ID:
NCT05902559
Condition:
Lung Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Participants eligible for Low Dose CT scan screening in the North Central London Targeted
Lung Health Check programme
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
55 Years
Maximum age:
74 Years
Locations:
Facility:
Name:
University College London Hospitals NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Chuen Ryan Khaw
Phone:
02034479005
Email:
c.khaw@ucl.ac.uk
Contact backup:
Last name:
Amyn Bhamani
Email:
a.bhamani@ucl.ac.uk
Investigator:
Last name:
Samuel Janes
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
November 20, 2028
Lead sponsor:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
University College, London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05902559
