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Early Cancer Detection Test - Lung Cancer Scotland (ECLS)

Primary Purpose

Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Early CDT Lung blood test

About this trial

This is an interventional screening trial for Lung Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Patients on prolonged / continuous use (> 3months) of cytotoxic/ immuno-suppressant drugs eg: Cyclophosphamide. Monotherapy using glucocorticoids/ steroids eg prednisolone is NOT an exclusion criteria.

Sites / Locations

NHS Tayside
NHS Greater Glasgow & Clyde
NHS Lanarkshire

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Early CDT Lung Test

Arm Description

participants monitored for 10 years for lung cancer incidence.

Early CDT lung blood test

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

Full Information

NCT ID

NCT01925625

First Posted

August 15, 2013

Last Updated

October 11, 2018

Sponsor

Stuart Schembri

1. Study Identification

Unique Protocol Identification Number

NCT01925625

Brief Title

Early Cancer Detection Test - Lung Cancer Scotland

Acronym

ECLS

Official Title

Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

August 31, 2018 (Actual)

Study Completion Date

August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stuart Schembri

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

AIMS To assess the effectiveness of EarlyCDT-Lung test in increasing early stage lung cancer detection, thereby reducing the rate of late stage (3 / 4 / U) presentation, compared to normal clinical practice; to assess the cost-effectiveness of EarlyCDT-Lung test compared to normal clinical practice; to assess the effectiveness of EarlyCDT-Lung test in reducing adverse outcomes including potential psychological and behavioural consequences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

participants monitored for 10 years for lung cancer incidence.

Arm Title

Early CDT Lung Test

Arm Type

Active Comparator

Arm Description

Early CDT lung blood test

Intervention Type

Biological

Intervention Name(s)

Early CDT Lung blood test

Other Intervention Name(s)

EarlyCDT-Lung test

Intervention Description

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.

Primary Outcome Measure Information:

Title

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;

Description

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;

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Patients on prolonged / continuous use (> 3months) of cytotoxic/ immuno-suppressant drugs eg: Cyclophosphamide. Monotherapy using glucocorticoids/ steroids eg prednisolone is NOT an exclusion criteria.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Sullivan, MbChB

Organizational Affiliation

University of Dundee

Official's Role

Principal Investigator

Facility Information:

Facility Name

NHS Tayside

City

Dundee

State/Province

Tayside

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

NHS Greater Glasgow & Clyde

City

Glasgow

Country

United Kingdom

Facility Name

NHS Lanarkshire

City

Wishaw

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

paticipant activity nearing closure

Citations:

PubMed Identifier

34551765

Citation

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.

Results Reference

derived

PubMed Identifier

32732334

Citation

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.

Results Reference

derived

PubMed Identifier

30227890

Citation

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.

Results Reference

derived

PubMed Identifier

28284200

Citation

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.

Results Reference

derived

Links:

URL

http://www.eclsstudy.org

Description

Study website

Learn more about this trial

Early Cancer Detection Test - Lung Cancer Scotland

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