Ovarian NeoplasmsCLOCSNCT03994653
Cancer Loyalty Card Study
An observational study of Ovarian Neoplasms, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Risk Factor Questionnaire and Clinical Questionnaire
- How many people
- 963 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2019to 28 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Loyalty Card Study: a Retrospective Observational Case-Control Study
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.
Read more
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.
Read the detailed description
Purpose and Design
The Cancer Loyalty Card Study (CLOCS) is addressing whether or not data already collected by high street retailers can detect significant changes in purchase behaviours of ovarian cancer patients prior to their diagnosis. The investigators aim to conduct a case-control study of ovarian cancer patients matched with women who do not have ovarian cancer. The study aims to recruit at least 500 recently diagnosed ovarian cancer patients and at least 500 healthy women as controls and collate up to 7 years of prior purchase data.
This is a database only study.
Recruitment
Loyalty card holders will be invited to join the study by email and post from the high street retailers and can choose to sign up via the CLOCS website or via post by returning the consent form to the study team through the mail. There will also be a press release about the study inviting loyalty card holders to visit the CLOCS website for more information and join the study. Women, 18 years or older, who have a loyalty card at the participating high street retailers are eligible to join. Women with ovarian cancer and who own at least one of the participating high street retailer's loyalty cards will be recruited in a clinic by a member of their healthcare team where the study is open. Any woman considering joining the study can contact the research team using the contact details on the information sheet.
Consent
Ovarian cancer patients will be given the information sheet and consent form in the clinic by a member of their healthcare team. They can take as much time as they need to read through the information sheet. If they choose to participate, they can complete the consent form whenever is convenient for them and return it to the CLOCS team in the free post envelope provided to them in the clinic.
Women without ovarian cancer will be presented with the information sheet and consent form in an email or letter in the mail from their high street retailer if they hold a loyalty card with them and return them to the CLOCS team in a free post envelope. They can also find the information sheet and consent form on the CLOCS website and consent online.
Methods
Consenting participants will complete a brief questionnaire about ovarian cancer risk factors, which will also be returned to the CLOCS team through the mail or on the website (healthy volunteers only). Participants with ovarian cancer will also have a clinical form for a member of their clinical team to complete in the clinic. This will be sent to the CLOCS team along with their consent and risk factor questionnaire in the free post envelope. Two ovarian cancer patients have reviewed all questionnaires and CLOCS documents and expressed their approval. Women without ovarian cancer from the general UK population have also reviewed the risk factor questionnaire and expressed their approval saying the questionnaire is 'easy to understand' and 'straightforward'.
If participants consent to be re-contacted by the CLOCS team for future studies or for loyalty card detail clarification,they will provide either a contact email or phone number. There is no further action needed from participants once they complete their consent form and questionnaire (and clarify loyalty card details if necessary)
- Conditions
- Ovarian Neoplasms
- Being tested
- Risk Factor Questionnaire, Clinical Questionnaire
- Keywords
- Ovarian cancer, Cancer of the ovary, Observational study, Case-control study, Cancer Loyalty Card Study, CLOCS
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Factor QuestionnaireOther
Also called Participant Questionnaire
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.
Clinical QuestionnaireOther
For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants diagnosed with ovarian cancer Receives: Other: Risk Factor Questionnaire; Other: Clinical Questionnaire | |
| Controls | Participants without ovarian cancer Receives: Other: Risk Factor Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Alert About Cancer Symptoms Assessed by Purchase Behaviour
The secondary outcome of the CLOCS will be defining a purchase threshold as an "alert" about cancer symptoms in individuals
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start4 Nov 2019
- Primary completion31 Jan 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Imperial College Healthcare NHS Trust, Sandwell & West Birmingham Hospitals NHS Trust, University College London Hospitals, County Durham and Darlington NHS Foundation Trust, Walsall Healthcare NHS Trust, Surrey and Sussex Healthcare NHS Trust, Airedale NHS Foundation Trust, Abertawe Bro Morgannwg University Health Board, Gateshead Health NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, NHS Lothian, East Lancashire Hospitals NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Royal Surrey County Hospital NHS Foundation Trust, Royal Marsden NHS Foundation Trust, Velindre NHS Trust, Cardiff and Vale University Health Board, South Tees Hospitals NHS Foundation Trust, West Hertfordshire Hospitals NHS Trust, The Christie NHS Foundation Trust, Manchester University NHS Foundation Trust, NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor
- Investigators
- James Flanagan, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994653
- Sponsor's protocol ID
- 19IC5156
- Acronym
- CLOCS
- Status last verified
- Jan 2025
- First submitted
- 19 Jun 2019
- Last updated
- 20 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated and anonymised survey data will be shared with other researchers after publication. No sensitive individual level data will be shared.
Publications
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.
PubMed 30664464Brewer 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.
PubMed 37316316Brewer 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.
PubMed 36701184Brewer 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.
PubMed 32900761
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Loyalty Card Study: a Retrospective Observational Case-Control Study
- ClinicalTrials.gov ID
- NCT03994653
- Acronym / sponsor ID
- CLOCS / 19IC5156
- Conditions
- Ovarian Neoplasms
- Keywords
- Ovarian cancer, Cancer of the ovary, Observational study, Case-control study, Cancer Loyalty Card Study, CLOCS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, Imperial College Healthcare NHS Trust, Sandwell & West Birmingham Hospitals NHS Trust, University College London Hospitals, County Durham and Darlington NHS Foundation Trust, Walsall Healthcare NHS Trust, Surrey and Sussex Healthcare NHS Trust, Airedale NHS Foundation Trust, Abertawe Bro Morgannwg University Health Board, Gateshead Health NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, NHS Lothian, East Lancashire Hospitals NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Royal Surrey County Hospital NHS Foundation Trust, Royal Marsden NHS Foundation Trust, Velindre NHS Trust, Cardiff and Vale University Health Board, South Tees Hospitals NHS Foundation Trust, West Hertfordshire Hospitals NHS Trust, The Christie NHS Foundation Trust, Manchester University NHS Foundation Trust, NHS Greater Glasgow and Clyde
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Posted 20 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose and Design
The Cancer Loyalty Card Study (CLOCS) is addressing whether or not data already collected by high street retailers can detect significant changes in purchase behaviours of ovarian cancer patients prior to their diagnosis. The investigators aim to conduct a case-control study of ovarian cancer patients matched with women who do not have ovarian cancer. The study aims to recruit at least 500 recently diagnosed ovarian cancer patients and at least 500 healthy women as controls and collate up to 7 years of prior purchase data.
This is a database only study.
Recruitment
Loyalty card holders will be invited to join the study by email and post from the high street retailers and can choose to sign up via the CLOCS website or via post by returning the consent form to the study team through the mail. There will also be a press release about the study inviting loyalty card holders to visit the CLOCS website for more information and join the study. Women, 18 years or older, who have a loyalty card at the participating high street retailers are eligible to join. Women with ovarian cancer and who own at least one of the participating high street retailer's loyalty cards will be recruited in a clinic by a member of their healthcare team where the study is open. Any woman considering joining the study can contact the research team using the contact details on the information sheet.
Consent
Ovarian cancer patients will be given the information sheet and consent form in the clinic by a member of their healthcare team. They can take as much time as they need to read through the information sheet. If they choose to participate, they can complete the consent form whenever is convenient for them and return it to the CLOCS team in the free post envelope provided to them in the clinic.
Women without ovarian cancer will be presented with the information sheet and consent form in an email or letter in the mail from their high street retailer if they hold a loyalty card with them and return them to the CLOCS team in a free post envelope. They can also find the information sheet and consent form on the CLOCS website and consent online.
Methods
Consenting participants will complete a brief questionnaire about ovarian cancer risk factors, which will also be returned to the CLOCS team through the mail or on the website (healthy volunteers only). Participants with ovarian cancer will also have a clinical form for a member of their clinical team to complete in the clinic. This will be sent to the CLOCS team along with their consent and risk factor questionnaire in the free post envelope. Two ovarian cancer patients have reviewed all questionnaires and CLOCS documents and expressed their approval. Women without ovarian cancer from the general UK population have also reviewed the risk factor questionnaire and expressed their approval saying the questionnaire is 'easy to understand' and 'straightforward'.
If participants consent to be re-contacted by the CLOCS team for future studies or for loyalty card detail clarification,they will provide either a contact email or phone number. There is no further action needed from participants once they complete their consent form and questionnaire (and clarify loyalty card details if necessary)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Risk Factor Questionnaire, Other: Clinical QuestionnaireParticipants diagnosed with ovarian cancer |
| Controls | – | Other: Risk Factor QuestionnaireParticipants without ovarian cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Factor QuestionnaireAlso: Participant QuestionnaireFor 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. | Other | Cases, Controls |
| Clinical QuestionnaireFor cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form. | Other | Cases |
Primary outcome
Purchase Behaviours (Purchase of Items)
Time frame: 24 months
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.
1 secondary outcome
Alert About Cancer Symptoms Assessed by Purchase Behaviour
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30664464Flanagan 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.
- Results publication: PubMed 37316316Brewer 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.
- Derived from this study: PubMed 36701184Brewer 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.
- Derived from this study: PubMed 32900761Brewer 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.
- Individual participant dataSharing planned: No. Only aggregated and anonymised survey data will be shared with other researchers after publication. No sensitive individual level data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Flanagan, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purchase Behaviours (Purchase of Items) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03994653, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.