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

Volumn 17, Issue 1, 2017, Pages

  Sullivan, F M ^a   Farmer, Eoghan ^b   Mair, Frances S ^c   Treweek, Shaun ^d   Kendrick, Denise ^e   Jackson, Cathy ^f   Robertson, Chris ^g   Briggs, Andrew ^c   McCowan, Colin ^c   Bedford, Laura ^h   Young, Ben ^h   Vedhara, Kavita ^e   Gallant, Stephanie ⁱ   Littleford, Roberta ⁱ   Robertson, John ^j   Sewell, Herb ^h   Dorward, Alistair ^k   Sarvesvaran, Joseph ^l   Schembri, Stuart ^m  

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY OF ST ANDREWS   (United Kingdom)

^c UNIVERSITY OF GLASGOW   (United Kingdom)

^d UNIVERSITY OF ABERDEEN   (United Kingdom)

^e UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^f UNIVERSITY OF CENTRAL LANCASHIRE   (United Kingdom)

^g UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^h QUEEN S MEDICAL CENTRE   (United Kingdom)

ⁱ UNIVERSITY OF DUNDEE   (United Kingdom)

^j UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^k NHS GREATER GLASGOW AND CLYDE   (United Kingdom)

^l QUEEN ELIZABETH UNIVERSITY HOSPITAL   (United Kingdom)

^m NINEWELLS HOSPITAL   (United Kingdom)

more..

Author keywords

Autoantibodies; Biomarker; Early diagnosis; Health economics; Lung cancer; Primary care; RCT; Screening

Indexed keywords

AUTOANTIBODY; BIOLOGICAL MARKER; TUMOR ANTIGEN;

ADULT; AGED; ARTICLE; BLOOD SAMPLING; CANCER DIAGNOSIS; CANCER RISK; CANCER STAGING; CANCER THERAPY; CASE FINDING; CLINICAL PROTOCOL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DIAGNOSTIC TEST; DISEASE MARKER; EARLYCDT LUNG TEST; HIGH RISK POPULATION; HUMAN; LUNG CANCER; MAJOR CLINICAL STUDY; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCOTLAND; THORAX RADIOGRAPHY; X RAY; BLOOD; COST BENEFIT ANALYSIS; DIAGNOSTIC IMAGING; EARLY CANCER DIAGNOSIS; ECONOMICS; FEMALE; IMMUNOLOGY; LUNG TUMOR; MALE; MASS SCREENING; MIDDLE AGED; PROCEDURES; SENSITIVITY AND SPECIFICITY; SURVIVAL ANALYSIS; X-RAY COMPUTED TOMOGRAPHY;

AGED; AUTOANTIBODIES; COST-BENEFIT ANALYSIS; EARLY DETECTION OF CANCER; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MASS SCREENING; MIDDLE AGED; NEOPLASM STAGING; SENSITIVITY AND SPECIFICITY; SURVIVAL ANALYSIS; TOMOGRAPHY, X-RAY COMPUTED; X-RAYS;

EID: 85014881385     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/s12885-017-3175-y     Document Type: Article

References (47)

1. Parkin DM, Whelan SL, Ferlay J et al. Cancer Incidence in Five Continents Volume VIII. IARC Sci. Publications. 2002;155.
2. Office for National Statistics (ONS). Cancer survival in England: patients diagnosed 2005-2009 and followed up to 2010. London: ONS; 2011.
3. ISD Scotland Cancer Mortality. [ http://www.isdscotland.org/Health-topics/Cancer/Publications/index.asp#605 ] Last accessed 9.11.14.
4. Cancer research UK. Cancer mortality-UK statistics. [ http://info.cancerresearchuk.org/cancerstats/mortality/ ] Last accessed 9.11.14.
5. Coleman MP, Forman D, Bryant H, Butler J, Rachet B, Maringe C, et al. Cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK (the international benchmarking partnership): an analysis of population-based cancer registry data. Lancet. 2011;377:127-38.
6. Weiss W, Boucot KR. The Philadelphia pulmonary neoplasm research project: early roentgenographic appearance of bronchogenic carcinoma. Arch Intern Med. 1974;134:306-11.
7. Lilienfeld A, Archer PG, Burnett CH, Chamberlain Chazin EW, Davies BJ, Davis D, Haber R, Hodges LPA, Koprowska FJIB, Kordan J, Lane Lawton TAH, Lee Jr L, MacCallum DB, McDonald JR, Milder JW, Naylor B, Papanicolaou GN, Slutzker B, Smith RT, Swepston ER, Umiker WO. An evaluation of radiographic and cytologic screening for the early detection of lung cancer: a cooperative pilot study of the American cancer society and the Veterans Administration. Cancer Res. 1966;26:2083-121.
8. Hayata Y, Funatsu H, Kato H, Saito Y, Sawamura K, Furose K. Results of lung cancer screening programmes in Japan. In: Band PR, editor. Early detection and localization of lung tumors in high risk groups, Recent results in cancer research, vol. 82. Berlin, Germany: Springer; 1982. p. 163-73.
9. Nash FA, Morgan JM, Tomkins JG. South London lung cancer study. BMJ. 1968;2:715-21.
10. Aberle D, Adams A, Berg C, Black W, Clapp J, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. National lung screening trial research team. New England J Med. 2011;365(5):395-409.
11. Field JK, et al. Prospects for population screening and diagnosis of lung cancer. Lancet. 2013;382:732-41.
12. Boyle P, Chapman C, Holdenrieder S, Murray A, Robertson C, Wood WC. Benefits and harms of CT screening for lung cancer. JAMA. 2012;307(22):2418-29.
13. Field JK, Duffy SW, Baldwin DR, Brain KE, Devaraj A, Eisen T, Green BA, Holemans JA, Kavanagh T, Kerr KM, Ledson M, Lifford KJ, McRonald FE, Nair A, Page RD, Parmar MK, Rintoul RC, Screaton N, Wald NJ, Weller D, Whynes DK, Williamson PR, Yadegarfar G, Hansell DM. The UK lung cancer screening trial: a pilot randomised controlled trial of low-dose computed tomography screening for the early detection of lung cancer. Health Technol Assess. 2016;20(40):1-146. doi: 10.3310/hta20400.
14. Chapman CJ, Healey GF, Murray A, Boyle P, Robertson C, Peek LJ, Allen J, Thorpe AJ, Hamilton-Fairley G, Parsy-Kowalska CB, MacDonald IK, Jewell W, Maddison P, Robertson JF. EarlyCDT®-lung test: improved clinical utility through additional autoantibody assays. Tumuor Biol. 2012;33(5):1319-26.
15. Mathew J, Healey G, Jewell W, Murray A, Chapman C, Peek L, et al. Demographics of populations at high risk of lung cancer and results of the early CDT-lung test. J Clin Oncol. 2010;28(15):7033.
16. Weller D, Vedsted P, Rubin G, Walter FM, Emery J, Scott S, Campbell C, Andersen RS, Hamilton W, Olesen F, Rose P, Nafees S, van Rijswijk E, Hiom S, Muth C, Beyer M, Neal RD. The Aarhus statement: improving design and reporting of studies on early cancer diagnosis. Br J Cancer. 2012;106(7):1262-7.
17. Scottish Index of Multiple Deprivation 2012. A National Statistics Publication for Scotland. 2012.
18. Kovalchik SA, et al. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013;369:245-54.
19. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone P. Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol. 1982;5:649-55.
20. Tayside Medical Science Centre. [ http://www.tasc-research.org.uk/ ] Last accessed 9.11.14.
21. Sullivan F, Hinds A, Pitkethly M, Treweek S, Wilson P, Wyke S. Primary care research network progress in Scotland. Eur J Gen Pract. 2014. doi: 10.3109/13814788.2013.879116.
22. Das N, et al. Exploring recruitment barriers and facilitators in early cancer detection trials: the use of pre-trial focus groups. Trials. 2014;15:98.
23. Flodgren G, Eccles MP, Shepperd S, Scott A, Parmelli E, Beyer FR. An overview of reviews evaluating the effectiveness of financial incentives in changing healthcare professional behaviours and patient outcomes. Cochrane Database Syst Rev. 2011;7.
24. Reekie D, Devlin H. Preventing failed appointments in general dental practice: a comparison of reminder methods. Br Dent J. 1998;185(9):472-4.
25. Edwards PJ, Roberts I, Clarke MJ, DiGuiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009;3.
26. ISD Scotland. Electronic Data Research and Innovation Service (eDRIS) [ http://www.isdscotland.org/Products-and-Services/eDRIS/ ] Last accessed 9.11.14.
27. Scottish Intercollegiate Guidelines Network. Management of patients with lung cancer. In: A national clinical guideline (SIGN 80), vol. 80. 2005.
28. Baldwin DR, White B, Schmidt-Hansen M, Champion AR, Melder AM, Guideline Development Group. Diagnosis and treatment of lung cancer: summary of updated NICE guidance. BMJ. 2011;342:d2110.
29. Devlin NJ, Krabbe PFM. The development of new research methods for the valuation of EQ-5D-5 L. Eur J Health Econ. 2013;14(1):S1-3.
30. Watson D, Clark L, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54(6):1063-70.
31. Moss-Morris R, Weinman J, Petrie KJ, Horne R, Cameron LD, Buick D. The revised illness perception questionnaire (IPQ-R). Psychol Health. 2002;17:1-16.
32. Snell Jr WE, Johnson G, Lloyd PJ, Hoover MW. The health orientation scale: a measure of psychological tendencies associated with health. Eur J Personality. 1991;5:169-83.
33. Lerman C, Trock B, Rimer BK, Jepson C, Brody D, Boyce A. Psychological side effects of breast cancer screening. Health Psychol. 1991;10:259-67.
34. Horowitz M, Wilner N, Alvarez W. Impact of event scale: a measure of subjective stress. Psychosom Med. 1979;41:209-18.
35. Swensen SJ, Jett JR, Hartman TE, et al. CT screening for lung cancer: five-year prospective experience. Radiology. 2005;235:259-65.
36. Stata Data and analysis software. Stata 13 [ http://www.stata.com/ ] Last accessed 9.11.14.
37. Van Iersel CA, De Koning HJ, Draisma G, Mali WP, Scholten ET, Nackaerts K, Prokop M, Habbema JD, Oudkerk M, Van Klaveren RJ. Risk-based selection from the general population in a screening trial: selection criteria, recruitment and power for the Dutch-Belgian randomised lung cancer multi-slice CT screening trial (NELSON). Int J Cancer. 2007;120(4):868-74.
38. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361-70.
39. NICE Discounting of health benefits in special circumstances [ http://www.nice.org.uk/media/955/4F/Clarification_to_section_5.6_of_the_Guide_to_Methods_of_Technology_Appraisals.pdf ] Last accessed 9.11.14.
40. Elliott P, Peakman TC. The UK Biobank sample handling and storage protocol for the collection, processing and archiving of human blood and urine. Int J Epidemiol. 2008;37(2):234-44.
41. Openclinica. [ https://www.openclinica.com/ ] Last accessed 9.11.14.
42. Tayside Medical Science Centre Data Management & Statistics. [ http://www.tasc-research.org.uk/_page.php?id=266 ] Last accessed 9.11.14.
43. IRMER. [ https://www.gov.uk/government/publications/the-ionising-radiation-medical-exposure-regulations-2000 ] Last accessed 9.11.14.
44. Research Governance Framework Scotland. [ http://www.cso.scot.nhs.uk/wp-content/uploads/2013/02/RGF-Second-Edition-February-06.pdf ] Last accessed 9.11.14.
45. Ashraf H, et al. Effect of CT screening on smoking habits at 1-year follow-up in the Danish Lung Cancer Screening Trial (DLCST). Thorax. 2009;64:388-92.
46. van der Aalst CM, et al. Lung cancer screening and smoking abstinence: 2 year follow-up data from the Dutch-Belgian randomised controlled lung cancer screening trial. Thorax. 2010;65:600-5.
47. Clark MM, et al. Effectiveness of smoking cessation self-help materials in a lung cancer screening population. Lung Cancer. 2004;44:13-21.