Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS): study protocol for a randomized controlled trial

F. M. Sullivan (Corresponding Author), Eoghan Farmer, Frances S Mair, Shaun Treweek, Denise Kendrick, Cathy Jackson, Chris Robertson, Andrew Briggs, Colin McCowan, Laura Bedford, Ben Young, Kavita Vedhara, Stephanie Gallant, Roberta Littleford, John Robertson, Herb Sewell, Alistair Dorward, Joseph Sarvesvaran, Stuart Schembri

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Abstract

Background Lung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT®-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis. The primary research question is: Does using the EarlyCDT®-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice? Methods A randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50–75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0–2) are eligible to participate. The intervention is the EarlyCDT®-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening. Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis. Discussion The study will determine the clinical and cost effectiveness of EarlyCDT®-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed. Trial registration NCT01925625. August 19, 2013
Original languageEnglish
Article number187
JournalBMC Cancer
Volume17
DOIs
Publication statusPublished - 11 Mar 2017

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Neoplasm Antigens
Autoantibodies
Lung Neoplasms
Randomized Controlled Trials
Lung
Cost-Benefit Analysis
X Ray Computed Tomography
Early Detection of Cancer
Thorax
Tomography
Psychology
Neoplasms
Mortality
Scotland
General Practice
Membrane Proteins
X-Rays
Morbidity
Costs and Cost Analysis
Incidence

Keywords

  • lung cancer
  • early diagnosis
  • screening
  • health economics
  • RCT
  • primary care
  • biomarker
  • autoantibodies

Cite this

Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS) : study protocol for a randomized controlled trial. / Sullivan, F. M. (Corresponding Author); Farmer, Eoghan; Mair, Frances S; Treweek, Shaun; Kendrick, Denise; Jackson, Cathy; Robertson, Chris; Briggs, Andrew; McCowan, Colin; Bedford, Laura ; Young, Ben ; Vedhara, Kavita ; Gallant, Stephanie ; Littleford, Roberta; Robertson, John; Sewell, Herb ; Dorward, Alistair; Sarvesvaran, Joseph ; Schembri, Stuart .

In: BMC Cancer, Vol. 17, 187, 11.03.2017.

Research output: Contribution to journalArticle

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 2017, 'Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS): study protocol for a randomized controlled trial' BMC Cancer, vol. 17, 187. https://doi.org/10.1186/s12885-017-3175-y
Sullivan, F. M. ; Farmer, Eoghan ; Mair, Frances S ; Treweek, Shaun ; Kendrick, Denise ; Jackson, Cathy ; Robertson, Chris ; Briggs, Andrew ; McCowan, Colin ; Bedford, Laura ; Young, Ben ; Vedhara, Kavita ; Gallant, Stephanie ; Littleford, Roberta ; Robertson, John ; Sewell, Herb ; Dorward, Alistair ; Sarvesvaran, Joseph ; Schembri, Stuart . / Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS) : study protocol for a randomized controlled trial. In: BMC Cancer. 2017 ; Vol. 17.
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abstract = "Background Lung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT{\circledR}-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis. The primary research question is: Does using the EarlyCDT{\circledR}-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice? Methods A randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50–75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0–2) are eligible to participate. The intervention is the EarlyCDT{\circledR}-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening. Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis. Discussion The study will determine the clinical and cost effectiveness of EarlyCDT{\circledR}-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed. Trial registration NCT01925625. August 19, 2013",
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TY - JOUR

T1 - Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS)

T2 - study protocol for a randomized controlled trial

AU - Sullivan, F. M.

AU - Farmer, Eoghan

AU - Mair, Frances S

AU - Treweek, Shaun

AU - Kendrick, Denise

AU - Jackson, Cathy

AU - Robertson, Chris

AU - Briggs, Andrew

AU - McCowan, Colin

AU - Bedford, Laura

AU - Young, Ben

AU - Vedhara, Kavita

AU - Gallant, Stephanie

AU - Littleford, Roberta

AU - Robertson, John

AU - Sewell, Herb

AU - Dorward, Alistair

AU - Sarvesvaran, Joseph

AU - Schembri, Stuart

N1 - Funding for the study was provided by the Chief Scientist Office, Scottish Government and Oncimmune Ltd.

PY - 2017/3/11

Y1 - 2017/3/11

N2 - Background Lung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT®-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis. The primary research question is: Does using the EarlyCDT®-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice? Methods A randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50–75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0–2) are eligible to participate. The intervention is the EarlyCDT®-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening. Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis. Discussion The study will determine the clinical and cost effectiveness of EarlyCDT®-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed. Trial registration NCT01925625. August 19, 2013

AB - Background Lung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT®-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis. The primary research question is: Does using the EarlyCDT®-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice? Methods A randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50–75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0–2) are eligible to participate. The intervention is the EarlyCDT®-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening. Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis. Discussion The study will determine the clinical and cost effectiveness of EarlyCDT®-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed. Trial registration NCT01925625. August 19, 2013

KW - lung cancer

KW - early diagnosis

KW - screening

KW - health economics

KW - RCT

KW - primary care

KW - biomarker

KW - autoantibodies

U2 - 10.1186/s12885-017-3175-y

DO - 10.1186/s12885-017-3175-y

M3 - Article

VL - 17

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

M1 - 187

ER -