NCT02612532

Brief Summary

The Lung Cancer Indicator Detection (LuCID) study investigates the the diagnostic accuracy of FAIMS for diagnosis of lung cancer by analysis of exhaled Volatile Organic Compounds.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,603

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable lung-cancer

Geographic Reach
4 countries

17 active sites

Status
completed

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 Start

First participant enrolled

October 7, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

5.4 years

First QC Date

November 18, 2015

Last Update Submit

June 16, 2023

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve for the diagnostic algorithm for lung cancer with optimal point sensitivity, specificity negative and positive predictive values.

    Diagnostic accuracy of VOC analysis for Lung Cancer diagnosis based on pattern recognition analysis of raw VOC-spectra generated by Lonestar analysis of breath.

    2 years

Secondary Outcomes (2)

  • Fraction of within group variability in exhaled VOCs explained by factors not primarily related to disease proces

    2 years

  • Identified exhaled biomarkers associated with tumor stage and size.

    2 years

Study Arms (1)

LuCID

EXPERIMENTAL

Standardised exhaled volatile organic compound collection by "ReCIVA" breath sampler (http://www.owlstonenanotech.com/medical/products/reciva) for analysis of volatile organic compounds by Lonestar (http://www.owlstonenanotech.com/medical/products/lonestar)

Device: ReCIVA breath sampler

Interventions

ReCIVA breath samplerDEVICE

Device developed for standardised collection of breath samples http://www.owlstonenanotech.com/medical/products/reciva

LuCID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years at time of consent
  • Referred for investigation due to suspicion of lung cancer
  • Referral based on suspicious symptoms
  • Referral based on suspicious finding on imaging, including CTscan with indeterminate nodule requiring follow-up evaluation.
  • Capable of understanding written and/or spoken language
  • Able to provide informed consent

You may not qualify if:

  • (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypo-ventilation, respiratory failure or claustrophobia when wearing the sampling mask
  • Participating in a Clinical Trial Investigational Medicinal Product (CTIMP)
  • Pulmonary function test with metacholine or beta-2-sympatico mimetic in last 2 hours.
  • Any lung biopsy in the past 48 hours
  • Currently undergoing anti-cancer treatment for lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

UZA University Hospital Antwerp

Antwerp, Belgium

Location

UZG University Hospital Gent

Ghent, Belgium

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

University Hospital Bari

Bari, Italy

Location

PapworthHospital

Cambridge, Cambridgeshire, United Kingdom

Location

Wycombe

Buckingham, United Kingdom

Location

University Hospital of Leicester

Leicester, United Kingdom

Location

University Hospital Aintree NHS Foundation Trust

Liverpool, United Kingdom

Location

University College London

London, United Kingdom

Location

Watford Hospital NHS Trust

London, United Kingdom

Location

University Hospital of South Manchester NHs Foundation Trust

Manchester, United Kingdom

Location

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

Location

Peterborough and Stamford Hospital

Peterborough, United Kingdom

Location

South Tyneside District Hospital

South Shields, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Royal Stoke University Hospital NHS Trust

Stoke, United Kingdom

Location

Wirral University Teaching Hospital NHS Foundation Trust

Upton, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marc P van der Schee, MD, PhD

    Owlstone Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 24, 2015

Study Start

October 7, 2015

Primary Completion

March 1, 2021

Study Completion

December 22, 2022

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

GB(13)IT(1)DE(1)BE(2)