NCT06447064

Brief Summary

Cancer is one of the leading causes of mortality worldwide and is responsible for an estimated 9.6 million deaths yearly. Cancer-related deaths can be reduced if patients are diagnosed and treated early. Delay in cancer diagnosis can occur at any point along the diagnostic spectrum, from the first observation of symptoms to the start of treatment. Diagnosing cancer when it is still at an early stage, before it has spread, gives surgery, radiotherapy and other treatments the best chance of working. Therefore, early diagnosis is the most important way to improve cancer outcomes.Most of the cancers usually presents with vague and non-alarming symptoms. Most individuals are diagnosed late when the cancer has already spread, and the prognosis is poor. There are over 200 different types of cancer that can cause many different signs and symptoms. Sometimes symptoms affect specific body areas, such as abdomen or skin. But signs can also be more general, and include weight loss, tiredness (fatigue) or unexplained pain. The type of symptoms varies from person to person. The major reasons for not presenting to the GP with symptoms such as these are "not wanting to waste the GP's time" and normalisation of these symptoms. The persistence of a symptom, social influence and awareness encourage help-seeking behaviours in primary care. However, few believe their symptom(s) might be a sign of cancer. Consequently, people might choose to self-manage their symptoms by using over-the-counter medication, and to seek advice from other sources, (pharmacists, family, internet), rather than a primary care physician. RATIONALE FOR CURRENT STUDY An early cancer diagnosis is essential for receiving treatment as early as possible to have the best chance for successful treatment. Early diagnosis of cancer can be challenging. Sometimes, the cancer symptoms resemble common illnesses and could resolve with the use of over-the-counter medications and other remedies until they become persistent or debilitating. The present study focuses on ten cancer forms: colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic. Patients diagnosed with the cancers mentioned above often report experiencing vague symptoms (such as abdominal or back pain, indigestion, feeling full etc). They often use over-the-counter medication to manage their symptoms before seeing a doctor. Information about how often and what products participants purchase (e.g. pain killers, digestive products and natural remedies) to care for these symptoms could help identify these cancers a few crucial weeks or months earlier and encourage people to seek help sooner from their doctors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,900

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress31%
Feb 2026Apr 2027

First Submitted

Initial submission to the registry

June 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

June 3, 2024

Last Update Submit

March 24, 2026

Conditions

Keywords

Ovarian CancerEpidemiologyObservational StudyRisk Assessment

Outcome Measures

Primary Outcomes (1)

  • Purchase behaviours (purchase of pain relief medications) assessed by Statistical Model

    The primary outcome of the CLOCS-2 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 a cancer diagnosis on a population level.

    3 years

Secondary Outcomes (3)

  • Alert about Cancer symptoms assessed by purchase behaviour

    3 years

  • Development of risk profiles for each cancer type

    3 years

  • Development of predictive model to assess utility of purchasing behaviours

    3 years

Study Arms (2)

Cases

Participants diagnosed with cancer.

Other: Cases & Controls

Controls

Participants not diagnosed with cancer.

Other: Cases & Controls

Interventions

Participants will complete a brief online questionnaire at REDCap about their health, clinical history and lifestyle choices. The participant will only need to provide a photo ID and utility bill for ID verification, if the retailer cannot match participant details. After recruitment the participants purchase history in the past 6 years will be requested from the retailers.

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults aged ≥18 years old, who own at least one participating high street retailer loyalty cad in their household. Among these individuals, those who have been diagnosed with any form of cancer as mentioned above (can join the CLOCS-2 as cases, and those who have no prior cancer diagnosis from the list of cancers mentioned above are eligible to join as controls.

You may qualify if:

  • Individuals aged \>18 years of age
  • Individuals must be residing in the United Kingdom at the time of giving informed consent
  • Individuals must be registered with an NHS GP Practice
  • Individuals must meet the criteria of ONE of the groups. For example, to be eligible for Group 1 (Cases), individuals must have been diagnosed with one of the following cancer types in the last 24 months: Bladder, colorectal (bowel), endometrial, liver, oesophageal, ovarian, pancreatic, stomach (gastric), uterine, or vulval; whereas for Group 2 (Controls), individuals must not have received a cancer diagnosis of any type in the last 6 years (except where the diagnosis was of non-melanoma skin cancer).
  • Individuals must be a primary registered cardholder\* of one of the loyalty cards listed below, and consent to share their loyalty card data with the study team
  • Tesco Clubcard
  • Boots Advantage Card
  • Provision of written informed consent
  • Willing and able to comply with all required study activities
  • The primary registered card holder, i.e., the person who is named on the loyalty card account, must also enrol into the study, if someone other than the registered primary card holder from the same household, wants to take part in the study.

You may not qualify if:

  • Individuals under the age of 18 years
  • Non-UK residents, at the time of giving informed consent
  • Individuals without an eligible loyalty card, or who have no one in their household who has an eligible loyalty card
  • Individuals who are not the primary registered cardholder in their household and where the primary registered loyalty card holder is not willing to join the study, and/or where the primary registered cardholder does not make purchases for or on behalf of the individual
  • Individuals will not be able to join as a case if:
  • they have been diagnosed with an eligible cancer type more than 24 months ago (except where the diagnosis was non-melanoma skin cancer).
  • they have received an ineligible cancer diagnosis within the last 6 years except where the diagnosis was non-melanoma skin cancer).
  • Individuals will not be able to join as a control (Group 2) if:
  • o they have received any cancer diagnosis in the last six years (except where the diagnosis was non-melanoma skin cancer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsColonic NeoplasmsEsophageal NeoplasmsStomach NeoplasmsLiver NeoplasmsUrinary Bladder NeoplasmsUterine NeoplasmsVulvar NeoplasmsOvarian NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesLiver DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleGenital DiseasesVulvar DiseasesOvarian DiseasesAdnexal DiseasesGonadal Disorders

Study Officials

  • Dr James Flanagan

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 6, 2024

Study Start

February 4, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

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