NCT03994653

Brief Summary

Approximately 7,400 new cases of ovarian cancer are diagnosed each year in the United Kingdom (UK), 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. The Cancer Loyalty Card Study (CLOCS) proposes to use loyalty card data from two participating high street retailers to investigate purchase behaviour as an opportunity for cancer symptom surveillance. The investigators 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
963

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 20, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

June 19, 2019

Results QC Date

February 6, 2023

Last Update Submit

January 17, 2025

Conditions

Ovarian Neoplasms

Keywords

Ovarian cancerCancer of the ovaryObservational studyCase-control studyCancer Loyalty Card StudyCLOCS

Outcome Measures

Primary Outcomes (1)

  • Purchase Behaviours (Purchase of Items)

    The primary outcome of the CLOCS will be to define the time by which the cases and controls are statistically significantly (p=0.05) different in their purchase behaviours leading up to ovarian cancer diagnosis. A higher purchase amount of relevant items (pain and indigestion medications) in cases compared to controls associated with cancer.

    24 months

Secondary Outcomes (1)

  • Alert About Cancer Symptoms Assessed by Purchase Behaviour

    3 years

Study Arms (2)

Cases

Participants diagnosed with ovarian cancer

Other: Risk Factor QuestionnaireOther: Clinical Questionnaire

Controls

Participants without ovarian cancer

Other: Risk Factor Questionnaire

Interventions

Risk Factor QuestionnaireOTHER

For cases, the study recruiter at the Trust will present this in the clinic. Controls will complete this online or at home when volunteering to participate. The participant questionnaire will be completed by the participant.

Also known as: Participant Questionnaire
CasesControls
Clinical QuestionnaireOTHER

For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.

Cases

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOvarian cancer is a female only cancer.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants will be females in the UK who are at least 18 years old and who own at least one of the participating high street retailer loyalty cards. Participants who have been diagnosed with ovarian cancer are considered cases. Participants who do not have ovarian cancer are considered controls.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Women under the age of 18 years and, since this is a study about ovarian cancer,men will not be eligible to join this study. Women who do not own loyalty cards with the participating high street retailers are not eligible to join this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (4)

  • Flanagan JM, Skrobanski H, Shi X, Hirst Y. Self-Care Behaviors of Ovarian Cancer Patients Before Their Diagnosis: Proof-of-Concept Study. JMIR Cancer. 2019 Jan 17;5(1):e10447. doi: 10.2196/10447.

    PMID: 30664464BACKGROUND

  • Brewer HR, Chadeau-Hyam M, Johnson E, Sundar S, Flanagan J, Hirst Y. Cancer Loyalty Card Study (CLOCS): feasibility outcomes for an observational case-control study focusing on the patient interval in ovarian cancer. BMJ Open. 2023 Jun 14;13(6):e066022. doi: 10.1136/bmjopen-2022-066022.

    PMID: 37316316RESULT

  • Brewer HR, Hirst Y, Chadeau-Hyam M, Johnson E, Sundar S, Flanagan JM. Association Between Purchase of Over-the-Counter Medications and Ovarian Cancer Diagnosis in the Cancer Loyalty Card Study (CLOCS): Observational Case-Control Study. JMIR Public Health Surveill. 2023 Jan 26;9:e41762. doi: 10.2196/41762.

    PMID: 36701184DERIVED

  • Brewer HR, Hirst Y, Sundar S, Chadeau-Hyam M, Flanagan JM. Cancer Loyalty Card Study (CLOCS): protocol for an observational case-control study focusing on the patient interval in ovarian cancer diagnosis. BMJ Open. 2020 Sep 8;10(9):e037459. doi: 10.1136/bmjopen-2020-037459.

    PMID: 32900761DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Results Point of Contact

Title
Dr James Flanagan
Organization
Imperial College London
j.flanagan@imperial.ac.uk
44 2075942127

Study Officials

  • James Flanagan, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 21, 2019

Study Start

November 4, 2019

Primary Completion

January 31, 2022

Study Completion

July 28, 2022

Last Updated

January 20, 2025

Results First Posted

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Only aggregated and anonymised survey data will be shared with other researchers after publication. No sensitive individual level data will be shared.

Locations

GB(1)