Trial Outcomes & Findings for Cancer Loyalty Card Study (NCT NCT03994653)

Last Updated: 2025-01-20

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

963 participants

Primary outcome timeframe

24 months

Results posted on

2025-01-20

Participant Flow

The target enrolment for this study was 1000. However, the study enrolled 963 participants (306 cases and 657 controls). 609 participants remained after confirming first part of eligibility (182 cases and 427 controls). 273 participants remained after confirming second part of eligibility (153 cases and 120 controls)

Participant milestones

Participant milestones
Measure	Cases Participants diagnosed with ovarian cancer Risk Factor 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 Questionnaire: For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.	Controls Participants without ovarian cancer Risk Factor 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.
Overall Study STARTED	306	657
Overall Study COMPLETED	153	120
Overall Study NOT COMPLETED	153	537

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cancer Loyalty Card Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cases n=182 Participants Participants diagnosed with ovarian cancer Risk Factor 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 Questionnaire: For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.	Controls n=427 Participants Participants without ovarian cancer Risk Factor 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.	Total n=609 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	98 Participants n=5 Participants	368 Participants n=7 Participants	466 Participants n=5 Participants
Age, Categorical >=65 years	84 Participants n=5 Participants	59 Participants n=7 Participants	143 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 10.9 • n=5 Participants	51.6 years STANDARD_DEVIATION 13.7 • n=7 Participants	55.5 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants	427 Participants n=7 Participants	609 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	181 Participants n=5 Participants	411 Participants n=7 Participants	592 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United Kingdom	182 participants n=5 Participants	427 participants n=7 Participants	609 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All participants for whom loyalty card data was received (cases and controls)

Outcome measures

Outcome measures
Measure	Cases n=153 Participants Participants diagnosed with ovarian cancer Risk Factor 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 Questionnaire: For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.	Controls n=120 Participants Participants without ovarian cancer Risk Factor 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.
Purchase Behaviours (Purchase of Items) 6 months (0-6)	3.2 number of items purchased Standard Deviation 8.4	2.0 number of items purchased Standard Deviation 3.0
Purchase Behaviours (Purchase of Items) 12 months (0-12)	5.9 number of items purchased Standard Deviation 13.6	4.3 number of items purchased Standard Deviation 6.3
Purchase Behaviours (Purchase of Items) 24 months (0-24)	11.4 number of items purchased Standard Deviation 25.0	8.5 number of items purchased Standard Deviation 11.4

SECONDARY outcome

Timeframe: 3 years

The secondary outcome of the CLOCS will be defining a purchase threshold as an "alert" about cancer symptoms in individuals

Outcome measures

Outcome data not reported

Adverse Events

Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr James Flanagan

Imperial College London

Phone: 44 2075942127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place