Condition category
Cancer
Date applied
16/09/2019
Date assigned
29/10/2019
Last edited
15/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The Cancer Loyalty Card Study (CLOCS) is addressing whether data already collected by high street retailers can detect significant changes in purchase behaviours of ovarian cancer patients prior to their diagnosis. The researchers aim to conduct a study of ovarian cancer patients matched with women who do not have ovarian cancer and collate up to 7 years of prior purchase data.

Who can participate?
Ovarian cancer patients aged 18 and older with loyalty cards at a participating high street retailer and women aged 18 and older who have not been diagnosed with ovarian cancer

What does the study involve?
Consenting participants provide their loyalty card details and complete a brief questionnaire about ovarian cancer risk factors, which is also returned to the CLOCS team through the mail or on the secure website (healthy volunteers only). Participants with ovarian cancer also have a clinical form for a member of their clinical team to complete in the clinic. This is sent to the CLOCS team along with their consent and risk factor questionnaire in a freepost envelope. If participants consent to be re-contacted by the CLOCS team for future studies or for loyalty card detail clarification, they provide either a contact email or phone number. There is no further action needed from participants once they complete and return their consent form and questionnaire (and clarify loyalty card details if necessary).

What are the possible benefits and risks of participating?
There are no clear risks in taking part in this study. However, it may be emotional or distressing to think about cancer and the first time a patient noticed some changes in their body. The researchers intended to design the survey questions in the most sensible and sensitive way to ensure that there are no negative effects of this study on patients’ well-being. To their knowledge, this study is a unique project which could have important public health benefits for women. If the study is successful, this could be instrumental in raising cancer symptom awareness in commercial settings.

Where is the study run from?
Imperial College London (UK)

When is the study starting and how long is it expected to run for?
February 2019 to June 2022

Who is funding the study?
Cancer Research UK

Who is the main contact?
Dr James Flanagan
j.flanagan@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Flanagan

ORCID ID

Contact details

Imperial College London
Division of Cancer
Department of Surgery and Cancer
Hammersmith Campus
Du Cane Road (Artillery Lane)
London
W12 0HS
United Kingdom
+44 (0)207 5942127
j.flanagan@imperial.ac.uk

Type

Scientific

Additional contact

Dr Hannah Brewer

ORCID ID

Contact details

Imperial College London
4th Floor
Institute of Reproductive and Developmental Biology (IRDB)
London
W12 0HS
United Kingdom
+44 (0)7503468620
h.brewer@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

NCT03994653

Protocol/serial number

CPMS: 43323

Study information

Scientific title

Cancer Loyalty Card Study (CLOCS)

Acronym

CLOCS

Study hypothesis

Approximately 7,400 new cases of ovarian cancer are diagnosed each year in the United Kingdom, and with over 4,000 women dying from the disease each year it is a particularly lethal form of cancer. The symptoms for ovarian cancer are not well known and vague, and most women are diagnosed at a late stage when the cancer has already spread around the abdominal cavity with poor prognosis. Novel methods are needed to improve earlier detection and thereby improve survival from this disease.

In the Cancer Loyalty Card Study (CLOCS) the researchers propose to use loyalty card data from two participating high street retailers to investigate purchase behaviour as an opportunity for cancer symptom surveillance. They aim to conduct a case-control study of ovarian cancer patients matched with women without ovarian cancer and to explore public preferences for how to communicate potential outcomes of the commercial and health data linkages back to individuals.

Ethics approval

Approved 11/09/2019, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House 4 Minshull Street Manchester M1 3DZ, UK; Tel: +44 (0)207 104 8010; Email: nrescommittee.northwest-gmsouth@nhs.net), REC ref: 19/NW/0427

Study design

Observational; Design type: Case-controlled study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Ovarian cancer

Intervention

Eligible participants will be women in the UK who own at least one loyalty card with the participating high street retailers. Of these women, those who have been diagnosed with ovarian cancer are eligible to participate in the study as cases, while women who have not been diagnosed with ovarian cancer are eligible to participate as controls.

Upon choosing to participate, all participants will be asked to complete a short questionnaire about well-established ovarian cancer risk factors and common symptoms either in the clinic (cases) or online/from a packet in the mail (controls). This information will be used in risk assessment for ovarian cancer of participants, which will be used at the analysis stage.

Once participant questionnaires and consent forms are returned to the CLOCS research team, only the researchers will have access to participants’ past purchase information already collected by high street retailers through the use of loyalty cards.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The time by which the cases and controls are statistically significantly different in their purchase behaviours leading up to diagnosis on a population level. Method: Data will be collected using questionnaire to establish ovarian cancer risk factors and clinical information; high street retailer loyalty cards data will be collected to establish an individual’s purchases and purchase behaviours. Timepoints: Participants will be recruited at baseline, and data collected at one timepoint (date of recruitment), and all data available up until that timepoint will be analysed.

Secondary outcome measures

The purchase threshold defined as an “alert” about cancer symptoms in individuals and the predictive utility of purchasing behaviours in the early detection of ovarian cancer. Exploratory analyses will include longitudinal analyses, frequency of purchases and unbiased analysis of other purchase categories. Method: Data will be collected using questionnaire to establish ovarian cancer risk factors and clinical information; high street retailer loyalty cards data will be collected to establish an individual’s purchases and purchase behaviours; Timepoints: Participants will be recruited at baseline, and data collected at one timepoint (date of recruitment), and all data available up until that timepoint will be analysed.

Overall trial start date

01/02/2019

Overall trial end date

30/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women, at least 18 years old, recently diagnosed with ovarian cancer (preferably recruited just after diagnosis and during treatment period, but are still eligible if diagnosed up to 2 years prior, at the latest) who hold at least one participating high street retailer loyalty card are eligible to join the CLOCS as cases
2. Women, at least 18 years old, who have not been diagnosed with ovarian cancer and hold at least one participating high street retailer loyalty card are eligible to join the CLOCS as controls

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 1000; UK Sample Size: 1000

Participant exclusion criteria

1. Women under the age of 18 years
2. Men

Recruitment start date

01/11/2019

Recruitment end date

31/10/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
Department of Surgery and Cancer Du Cane Road (Artillery Lane)
London
W12 0HS
United Kingdom

Trial participating centre

Imperial College Healthcare NHS Trust
St Marys Hospital Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

Sandwell and West Birmingham Hospitals NHS Trust
City Hospital Dudley Road
Birmingham
B18 7QH
United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom

Trial participating centre

County Durham and Darlington NHS Foundation Trust
Darlington Memorial Hospital Hollyhurst Road
Darlington
DL3 6HX
United Kingdom

Trial participating centre

Walsall Healthcare NHS Trust
Manor Hospital Moat Road
Walsall
WS2 9PS
United Kingdom

Trial participating centre

Surrey and Sussex Healthcare NHS Trust
East Surrey Hospital Canada Avenue
Redhill
RH1 5RH
United Kingdom

Trial participating centre

Airedale NHS Foundation Trust
Airedale General Hospital Skipton Road Steeton
Keighley
BD20 6TD
United Kingdom

Trial participating centre

Abertawe Bro Morgannwg University LHB
One Talbot Gateway, Seaway Drive Seaway Parade Industrial Estate Baglan
Port Talbot
SA12 7BR
United Kingdom

Trial participating centre

Gateshead Health NHS Foundation Trust
Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane Colney
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
St. James's University Hospital Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

NHS Lothian
Waverley Gate 2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom

Trial participating centre

East Lancashire Hospitals NHS Trust
Royal Blackburn Hospital Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
Marlborough Street
Bristol
BS1 3NU
United Kingdom

Trial participating centre

Royal Surrey County Hospital NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom

Trial participating centre

The Royal Marsden NHS Foundation Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Trial participating centre

Velindre NHS Trust
Unit 2 Charnwood Court Heol Billingsley
Cardiff
CF15 7QZ
United Kingdom

Trial participating centre

Cardiff & Vale University LHB
Corporate Headquarters Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
James Cook University Hospital Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

West Hertfordshire Hospitals NHS Trust
Trust Offices Watford General Hospital Vicarage Road
Watford
WD18 0HB
United Kingdom

Trial participating centre

The Christie NHS Foundation Trust
550 Wilmslow Road Withington
Manchester
M20 4BX
United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Cobbett House Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

Imperial College of Science, Technology and Medicine

Sponsor details

c/o Becky Ward
215
2nd Floor
Norfolk Place
St Mary's Campus
London
W2 1PG
United Kingdom
+44 (0)20 7594 9459
becky.ward@imperial.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK; Grant Codes: C38463/A26726

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Peer reviewed scientific journals
2. Conference presentation
3. Publication on website

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to fact that the raw data contains participant identifiable data and only the anonymised risk factor questionnaire data will be made available to collaborators upon reasonable request.

Intention to publish date

30/06/2023

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/11/2019: Internal review. 16/09/2019: Trial's existence confirmed by the NIHR.