Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis

Introduction Ovarian cancer is the eighth most common cancer in women worldwide, and about 1 in 5 women with ovarian cancer do not receive treatment, because they are too unwell by the time they are diagnosed. Symptoms of ovarian cancer are non-specific or can be associated with other common conditi...

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Main Authors: Marc Chadeau-Hyam, Sudha Sundar, Yasemin Hirst, Hannah R Brewer, James M Flanagan
Format: Article
Language:English
Published: BMJ Publishing Group 2020-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/9/e037459.full
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author Marc Chadeau-Hyam
Sudha Sundar
Yasemin Hirst
Hannah R Brewer
James M Flanagan
author_facet Marc Chadeau-Hyam
Sudha Sundar
Yasemin Hirst
Hannah R Brewer
James M Flanagan
author_sort Marc Chadeau-Hyam
collection DOAJ
description Introduction Ovarian cancer is the eighth most common cancer in women worldwide, and about 1 in 5 women with ovarian cancer do not receive treatment, because they are too unwell by the time they are diagnosed. Symptoms of ovarian cancer are non-specific or can be associated with other common conditions, and women experiencing these symptoms have been shown to self-manage them using over-the-counter medication. Results from a recent proof-of-concept study suggest there may be an increase in the purchases of painkillers and indigestion medication 10–12 months before ovarian cancer diagnosis. We propose a case–control study, as part of a larger project called the Cancer Loyalty Card Study (CLOCS), to investigate whether a significant change in medication purchases could be an indication for early signs of ovarian cancer, using data already collected through store loyalty cards.Methods and analysis Using a retrospective case–control design, we aim to recruit 500 women diagnosed with ovarian cancer (cases) and 500 women without ovarian cancer (controls) in the UK who hold a loyalty card with at least one participating high street retailer. We will use pre-existing loyalty card data to compare past purchase patterns of cases with those of controls. In order to assess ovarian cancer risk in participants and their purchase patterns, we will collect information from participants on ovarian cancer risk factors and clinical data including symptoms experienced before diagnosis from recruited women with ovarian cancer.Ethics and dissemination CLOCS was reviewed and approved by the North West-Greater Manchester South Research Ethics Committee (19/NW/0427). Study outcomes will be disseminated through academic publications, the study website, social media and a report to the research sites that support the study once results are published.Trial registration number ISRCTN 14897082, CPMS 43323, NCT03994653.
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spelling doaj.art-f62b5d8352dd47cf827235726d3c136d2025-01-09T01:50:10ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037459Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosisMarc Chadeau-Hyam0Sudha Sundar1Yasemin Hirst2Hannah R Brewer3James M Flanagan4MRC Centre for Environment and Health, Imperial College London, London, UK3 Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UKEpidemiology and Public Health, University College London, London, UKDepartment of Surgery and Cancer, Imperial College London, London, UK1 Surgery and Cancer, Imperial College London, London, UKIntroduction Ovarian cancer is the eighth most common cancer in women worldwide, and about 1 in 5 women with ovarian cancer do not receive treatment, because they are too unwell by the time they are diagnosed. Symptoms of ovarian cancer are non-specific or can be associated with other common conditions, and women experiencing these symptoms have been shown to self-manage them using over-the-counter medication. Results from a recent proof-of-concept study suggest there may be an increase in the purchases of painkillers and indigestion medication 10–12 months before ovarian cancer diagnosis. We propose a case–control study, as part of a larger project called the Cancer Loyalty Card Study (CLOCS), to investigate whether a significant change in medication purchases could be an indication for early signs of ovarian cancer, using data already collected through store loyalty cards.Methods and analysis Using a retrospective case–control design, we aim to recruit 500 women diagnosed with ovarian cancer (cases) and 500 women without ovarian cancer (controls) in the UK who hold a loyalty card with at least one participating high street retailer. We will use pre-existing loyalty card data to compare past purchase patterns of cases with those of controls. In order to assess ovarian cancer risk in participants and their purchase patterns, we will collect information from participants on ovarian cancer risk factors and clinical data including symptoms experienced before diagnosis from recruited women with ovarian cancer.Ethics and dissemination CLOCS was reviewed and approved by the North West-Greater Manchester South Research Ethics Committee (19/NW/0427). Study outcomes will be disseminated through academic publications, the study website, social media and a report to the research sites that support the study once results are published.Trial registration number ISRCTN 14897082, CPMS 43323, NCT03994653.https://bmjopen.bmj.com/content/10/9/e037459.full
spellingShingle Marc Chadeau-Hyam
Sudha Sundar
Yasemin Hirst
Hannah R Brewer
James M Flanagan
Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis
BMJ Open
title Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis
title_full Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis
title_fullStr Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis
title_full_unstemmed Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis
title_short Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis
title_sort cancer loyalty card study clocs protocol for an observational case control study focusing on the patient interval in ovarian cancer diagnosis
url https://bmjopen.bmj.com/content/10/9/e037459.full
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