NCT01925625

Brief Summary

HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,210

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

3 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

August 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

5.1 years

First QC Date

August 15, 2013

Last Update Submit

October 11, 2018

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • to assess the effectiveness of EarlyCDT-Lung test in reducing the incidence of patients with late-stage lung cancer at diagnosis, compared with standard clinical practice;

    difference at 24 months after randomisation, between the number of patients with stage 3, 4 or unclassified lung cancer at diagnosis in the intervention arm, and those in the control arm;

    24 months

Study Arms (2)

Control

NO INTERVENTION

participants monitored for 10 years for lung cancer incidence.

Early CDT Lung Test

ACTIVE COMPARATOR

Early CDT lung blood test

Biological: Early CDT Lung blood test

Interventions

Early CDT Lung blood testBIOLOGICAL

The EarlyCDT-Lung Test is an early detection test designed to assist in lung cancer risk assessment and detection in the earliest stages of the disease.

Also known as: EarlyCDT-Lung test
Early CDT Lung Test

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study
  • Male or female aged 50 years to 75 years
  • Current or Ex-smoker with at least 20 year pack history
  • or Less than 20 year pack history but with family history of lung cancer in a 1st degree relative (mother, father, sister, brother, child)
  • ECOG Status: 0, 1 and 2 (Eastern Co-operative Oncology Group) Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  • Geographical postal sectors of:
  • NHS Geographical Area Eligible Postcodes Tayside DD1 - DD11, PH1-PH3 , PH6-PH8, PH10, PH11, PH13, PH15 \& PH16 Greater Glasgow \& Clyde G1-G5, G11 -G15, G20-G22, G31-34, G40 -G46, G51- G53, G60-G62 \&G64, G66 \& G69, G72 \& G73, G76-G78, G81-G83 PA1-PA8 (except PA6), PA11-PA16 \& PA19

You may not qualify if:

  • History of any cancer other than non-melanomatous skin cancer, cervical cancer in situ.
  • Symptoms suggestive of lung cancer within past 6 months (haemoptysis, unintentional weight loss (at least 5% in preceding 6 months).
  • Patients for whom the GP considers invitation to the study would cause undue distress.
  • Patients with other terminal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NHS Tayside

Dundee, Tayside, DD1 9SY, United Kingdom

Location

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Location

NHS Lanarkshire

Wishaw, United Kingdom

Location

Related Publications (5)

  • Romeikat NL, Sullivan F, Daly F, Kong W. The Importance of Comorbidities at Baseline and 5-Year Follow-Up in a Lung Cancer Biomarker Screening Trial. J Clin Med. 2025 Mar 20;14(6):2116. doi: 10.3390/jcm14062116.

    PMID: 40142924DERIVED

  • Madurasinghe VW, Bower P, Eldridge S, Collier D, Graffy J, Treweek S, Knapp P, Parker A, Rick J, Salisbury C, Man MS, Torgerson D, Sheridan R, Sullivan F, Cockayne S, Dack C. Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets. BMC Med. 2021 Sep 23;19(1):218. doi: 10.1186/s12916-021-02086-2.

    PMID: 34551765DERIVED

  • Sullivan FM, Mair FS, Anderson W, Armory P, Briggs A, Chew C, Dorward A, Haughney J, Hogarth F, Kendrick D, Littleford R, McConnachie A, McCowan C, McMeekin N, Patel M, Rauchhaus P, Ritchie L, Robertson C, Robertson J, Robles-Zurita J, Sarvesvaran J, Sewell H, Sproule M, Taylor T, Tello A, Treweek S, Vedhara K, Schembri S; Early Diagnosis of Lung Cancer Scotland (ECLS) Team. Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging. Eur Respir J. 2021 Jan 14;57(1):2000670. doi: 10.1183/13993003.00670-2020. Print 2021 Jan.

    PMID: 32732334DERIVED

  • Parker A, Knapp P, Treweek S, Madhurasinghe V, Littleford R, Gallant S, Sullivan F, Schembri S, Rick J, Graffy J, Collier DJ, Eldridge S, Kennedy A, Bower P. The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial. Trials. 2018 Sep 18;19(1):503. doi: 10.1186/s13063-018-2896-9.

    PMID: 30227890DERIVED

  • Sullivan FM, Farmer E, Mair FS, Treweek S, Kendrick D, Jackson C, Robertson C, Briggs A, McCowan C, Bedford L, Young B, Vedhara K, Gallant S, Littleford R, Robertson J, Sewell H, Dorward A, Sarvesvaran J, Schembri S. Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT(R)-Lung Test (ECLS): study protocol for a randomized controlled trial. BMC Cancer. 2017 Mar 11;17(1):187. doi: 10.1186/s12885-017-3175-y.

    PMID: 28284200DERIVED

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Frank Sullivan, MbChB

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 20, 2013

Study Start

August 1, 2013

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

GB(3)