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Socioeconomic Inequalities in the Diagnosis and Treatment of Colon and Ovarian Cancer in England Between 2016-2017

Sponsor
University of Hull (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05185388
Collaborator
(none)
45,831
Enrollment
1
Location
50.2
Anticipated Duration (Months)
912.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    45831 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Oct 25, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Inequalities in time to diagnosis and/or treatment [January 2016 - December 2017]

      Any differences in time to diagnosis or treatment of colon or ovarian cancer, adjusting for important factors

    2. Inequalities in treatments received [January 2016 - December 2017]

      Any differences in treatments received for colon or ovarian cancer, adjusting for important factors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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.

    Exclusion Criteria:

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hull York Medical School Hull Humberside United Kingdom HU6 7TS

    Sponsors and Collaborators

    • University of Hull

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Una Macleod, Dean / Professor of Primary Care Medicine, University of Hull
    ClinicalTrials.gov Identifier:
    NCT05185388
    Other Study ID Numbers:
    • RS154-ODR-BPS
    First Posted:
    Jan 11, 2022
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Una Macleod, Dean / Professor of Primary Care Medicine, University of Hull
    Socioeconomic Inequalities
    Additional relevant MeSH terms:
    Neoplasms, Second Primary
    Disease

    Study Results

    No Results Posted as of Jan 11, 2022