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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05185388
Other study ID # RS154-ODR-BPS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 25, 2021
Est. completion date December 2027

Study information

Verified date January 2024
Source University of Hull
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45831
Est. completion date December 2027
Est. primary completion date November 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Locations

Country Name City State
United Kingdom Hull York Medical School Hull Humberside

Sponsors (1)

Lead Sponsor Collaborator
University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 January 2016 - December 2017
Primary Inequalities in treatments received Any differences in treatments received for colon or ovarian cancer, adjusting for important factors January 2016 - December 2017
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