Treatment Related CancerNCT05185388
Socioeconomic Inequalities in the Diagnosis and Treatment of Colon and Ovarian Cancer in England Between 2016-2017
An observational study of Treatment Related Cancer and Diagnoses Disease, run by University of Hull at 1 site in United Kingdom.
Trial summary
This study is a population-based, patient-level analysis of colon and ovarian cancer diagnoses in England over a 2-year period using a dataset created by linking NCRAS and NHS digital datasets. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Treatment Related Cancer, Diagnoses Disease, Equality, Gender
- How many people
- 45,831 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with colon and ovarian cancer diagnosed between 01/01/2016 and 31/12/2017 in England will be considered for inclusion in the study, according to specific inclusion and exclusion criteria.
Who may be able to join
- All patients resident in England and aged 18-99 diagnosed with colon cancer (ICD10 C18) or ovarian cancer (ICD10 C48, C56, C57 and D39,1) where the date of diagnosis is between 01/01/2016 and 31/12/2017.
Who cannot join
- Patients with cancers of the appendix (C18.1) will be excluded.
- Male patients with ovarian cancer.
- Borderline ovarian tumours (ICD-10 site code of C56x, C57x or C48x where the morphology code is: 8442, 8444, 8451, 8463, 8473, 8472 or 8462) and (ICD-10 site code D39.1 where the morphology code is 8144, 8260, 8313, 8380, 8381, 8440, 8441, 8460, 8470, 8480, 8481, 9000, 9013, 9014 or 9015).
- Sarcomas are excluded (where the morphology code is: 8693, 8800-8806, 8963, 8990-8991, 9040-9044, 8810, 8811-8921, 9120-9373, 9490, 9500, 9530-9582).
- Patients diagnosed with any prior invasive primary malignancies (ICD10 C00-97x), where the date of diagnosis of such prior invasive malignancies precedes the diagnosis date of the first qualifying tumour. Patients with a synchronous diagnosis on the same day as their qualifying tumour will be included within the sample population.
- Incomplete registrations excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull York Medical School
Hull, Humberside, HU6 7TS
About this study
Official title: Socioeconomic Inequalities in the Diagnosis and Treatment of Colon and Ovarian Cancer in England Between 2016-2017: A Data Linkage Study Linking National Cancer Registration and Analysis Service, Hospital Episode Statistics and NHS Digital Datasets
This study is a population-based, patient-level analysis of colon and ovarian cancer diagnoses in England over a 2-year period using a dataset created by linking NCRAS and NHS digital datasets. Our analyses will look into inequalities in the diagnostic and treatment pathway, and inequalities in treatment received, for those diagnosed with colon and ovarian cancer between 2016-2017.
Read the detailed description
Colon and ovarian cancer survival in England lags behind other comparable countries. There is also evidence of a deprivation gradient in survival in England, where those from the most deprived areas are more likely to experience a worse survival with the disease.
Inequalities in the diagnostic and treatment pathways, and in treatments received, may contribute to this deprivation gap in survival. This study will look at the secondary care diagnostic interval and the treatment interval to assess for any socioeconomic inequalities in both these intervals. This study will also look at anticancer treatments received (surgery, chemotherapy and the combination of both treatment modalities) to evaluate for any socioeconomic inequalities in treatments received.
Important variables will be adjusted for in statistical modelling, including age, co-morbidities, ethnicity and stage of disease
To evaluate for inequalities in treatments received and diagnostic and treatment intervals the study will use data from the cancer registry, Systemic Anticancer Therapy (SACT), Hospital Episodes Statistics, Diagnostic Imaging Dataset and Cancer Waiting Times datasets. These datasets will be linked by the National Cancer Registration and Analysis Service, using a unique identifier. We will receive a pseudo-anonymised dataset, allowing for patient-level analyses but without identifying individual patients.
- Keywords
- Socioeconomic Inequalities
- Medical subject headings
- Neoplasms, Second Primary, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Inequalities in time to diagnosis and/or treatment
Any differences in time to diagnosis or treatment of colon or ovarian cancer, adjusting for important factors
Measured: January 2016 - December 2017
Inequalities in treatments received
Any differences in treatments received for colon or ovarian cancer, adjusting for important factors
Measured: January 2016 - December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start25 Oct 2021
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment Related CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185388
- Sponsor's protocol ID
- RS154-ODR-BPS
- Status last verified
- May 2026
- First submitted
- 22 Dec 2021
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pickwell-Smith BA, Paton LW, Soyiri I, Lind M, Macleod U. Are there inequalities in colon cancer diagnosis and treatment in England? A population-based study. Cancer Epidemiol. 2026 Sep 12;105:103230. doi: 10.1016/j.canep.2026.103230. Online ahead of print.
PubMed 42731437Pickwell-Smith BA, Paton LW, Soyiri I, Lind M, Macleod U. Are there inequalities in ovarian cancer diagnosis and treatment in England? A population-based study. Cancer Epidemiol. 2025 Jun;96:102778. doi: 10.1016/j.canep.2025.102778. Epub 2025 Mar 8.
PubMed 40058114
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Inequalities in the Diagnosis and Treatment of Colon and Ovarian Cancer in England Between 2016-2017: A Data Linkage Study Linking National Cancer Registration and Analysis Service, Hospital Episode Statistics and NHS Digital Datasets
- ClinicalTrials.gov ID
- NCT05185388
- Acronym / sponsor ID
- RS154-ODR-BPS
- Keywords
- Socioeconomic Inequalities
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45,831 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a population-based, patient-level analysis of colon and ovarian cancer diagnoses in England over a 2-year period using a dataset created by linking NCRAS and NHS digital datasets. Our analyses will look into inequalities in the diagnostic and treatment pathway, and inequalities in treatment received, for those diagnosed with colon and ovarian cancer between 2016-2017.
Detailed description
Colon and ovarian cancer survival in England lags behind other comparable countries. There is also evidence of a deprivation gradient in survival in England, where those from the most deprived areas are more likely to experience a worse survival with the disease.
Inequalities in the diagnostic and treatment pathways, and in treatments received, may contribute to this deprivation gap in survival. This study will look at the secondary care diagnostic interval and the treatment interval to assess for any socioeconomic inequalities in both these intervals. This study will also look at anticancer treatments received (surgery, chemotherapy and the combination of both treatment modalities) to evaluate for any socioeconomic inequalities in treatments received.
Important variables will be adjusted for in statistical modelling, including age, co-morbidities, ethnicity and stage of disease
To evaluate for inequalities in treatments received and diagnostic and treatment intervals the study will use data from the cancer registry, Systemic Anticancer Therapy (SACT), Hospital Episodes Statistics, Diagnostic Imaging Dataset and Cancer Waiting Times datasets. These datasets will be linked by the National Cancer Registration and Analysis Service, using a unique identifier. We will receive a pseudo-anonymised dataset, allowing for patient-level analyses but without identifying individual patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with colon and ovarian cancer diagnosed between 01/01/2016 and 31/12/2017 in England will be considered for inclusion in the study, according to specific inclusion and exclusion criteria.
Key inclusion criteria (1 listed)
- All patients resident in England and aged 18-99 diagnosed with colon cancer (ICD10 C18) or ovarian cancer (ICD10 C48, C56, C57 and D39,1) where the date of diagnosis is between 01/01/2016 and 31/12/2017.
Key exclusion criteria (6 listed)
- Patients with cancers of the appendix (C18.1) will be excluded.
- Male patients with ovarian cancer.
- Borderline ovarian tumours (ICD-10 site code of C56x, C57x or C48x where the morphology code is: 8442, 8444, 8451, 8463, 8473, 8472 or 8462) and (ICD-10 site code D39.1 where the morphology code is 8144, 8260, 8313, 8380, 8381, 8440, 8441, 8460, 8470, 8480, 8481, 9000, 9013, 9014 or 9015).
- Sarcomas are excluded (where the morphology code is: 8693, 8800-8806, 8963, 8990-8991, 9040-9044, 8810, 8811-8921, 9120-9373, 9490, 9500, 9530-9582).
- Patients diagnosed with any prior invasive primary malignancies (ICD10 C00-97x), where the date of diagnosis of such prior invasive malignancies precedes the diagnosis date of the first qualifying tumour. Patients with a synchronous diagnosis on the same day as their qualifying tumour will be included within the sample population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inequalities in time to diagnosis and/or treatment
Time frame: January 2016 - December 2017
Any differences in time to diagnosis or treatment of colon or ovarian cancer, adjusting for important factors
Inequalities in treatments received
Time frame: January 2016 - December 2017
Any differences in treatments received for colon or ovarian cancer, adjusting for important factors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 42731437Pickwell-Smith BA, Paton LW, Soyiri I, Lind M, Macleod U. Are there inequalities in colon cancer diagnosis and treatment in England? A population-based study. Cancer Epidemiol. 2026 Sep 12;105:103230. doi: 10.1016/j.canep.2026.103230. Online ahead of print.
- Derived from this study: PubMed 40058114Pickwell-Smith BA, Paton LW, Soyiri I, Lind M, Macleod U. Are there inequalities in ovarian cancer diagnosis and treatment in England? A population-based study. Cancer Epidemiol. 2025 Jun;96:102778. doi: 10.1016/j.canep.2025.102778. Epub 2025 Mar 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Treatment Related Cancer and Diagnoses Disease, run by University of Hull 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Inequalities in time to diagnosis and/or treatment (time frame: January 2016 - December 2017). The study lists 2 primary outcomes in all. 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 NCT05185388, which also lists 2 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 11 May 2026.