Clinical trial NCT01925625: Early Cancer Detection Test - Lung Cancer Scotland
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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 12210
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female aged 50 years to 75 years
3. Current or Ex-smoker with at least 20 year pack history
4. or Less than 20 year pack history but with family history of lung cancer in a 1st degree relative (mother, father, sister, brother, child)
5. 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
6. 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:

1. History of any cancer other than non-melanomatous skin cancer, cervical cancer in situ.
2. Symptoms suggestive of lung cancer within past 6 months (haemoptysis, unintentional weight loss (at least 5% in preceding 6 months).
3. Patients for whom the GP considers invitation to the study would cause undue distress.
4. Patients with other terminal disease.
5. Patients on prolonged / continuous use (\> 3months) of cytotoxic/ immuno-suppressant drugs eg: Cyclophosphamide. Monotherapy using glucocorticoids/ steroids eg prednisolone is NOT an exclusion criteria.

Primary outcomes:
measure: 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;
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: NHS Tayside
state: Tayside
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
city: Wishaw
country: United Kingdom
facility: NHS Lanarkshire
Study officials:
affiliation: University of Dundee
name: Frank Sullivan, MbChB
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.