Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05835947 |
| Other study ID # |
315094 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
October 1, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a retrospective cross-sectional study involving the analysis of Cancer Registry Data.
As part of this study, cancer registration data collated by the National Cancer Registration
and Analysis Service (NCRAS; the national cancer registry in England), via NHS Digital data
access request service (DARS), will be analysed on all female patients aged between 25-90+
years in England with a registered diagnosis of anal and vaginal and/or vulvar and/or
cervical cancer and/or high grade squamous intraepithelial lesions (HSIL) between 2001 and
2019. For these patients information on age at diagnosis, ethnicity, deprivation, performance
status, stage of the cancer at diagnosis, the date of each diagnosis, the treatment received
for the diagnosis and the route to diagnosis, will be analysed. Additionally, the total
number of women/year (between 1995 and 2019), in England, aged between 25-90+ years with a
diagnosis of anal, vulvar, vaginal and cervical cancer as well as their respective HSILs will
be requested. Together this data will be used to establish the incidence of anal cancer and
HSIL in women with genital cancers and/or HSILs, the progression timelines between the
different pathologies, as well as identify relevant sociodemographic risk factors in this
patient group.
Description:
Hypothesis: Women with genital HSILs/SCCs have an increased risk of anal HSIL/SCC regardless
of whether they have received treatment for their genital condition and would benefit from
surveillance and treatment of anal HSIL in the prevention of ASCC.
This is a retrospective observational (cross sectional) study in which de-personalised
patient level National Cancer Registration and Analysis Service data via NHS Digital DARS
will be requested.
In particular, patient level data for all women in England, between 2001 and 2019, aged 25-
90+ years, with a diagnosis of anal cancer and/or anal HSIL and:
- vaginal SCC and/or HSIL
- vulvar SCC and/or HSIL
- cervical SCC and/or HSIL
- vaginal and vulvar SCC and/or HSIL
- vaginal and cervical SCC and/or HSIL
- vulvar and cervical SCC and/or HSIL
- vaginal, cervical and vulvar SCC and/or HSIL
For these women with synchronous or metachronous anal and genital HSILs or SCCs data will be
collected on:
1. Month, Year of each diagnosis.
2. Age at each diagnosis.
3. Cancer stage (for each cancer): 1, 2, 3, 4, not known, other, unstageable disease.
4. Performance status at each diagnosis: 1,2,3,4, not known.
5. Treatments received (for each diagnosis): Surgery, Chemotherapy, Radiotherapy.
6. Ethnicity: British, Irish, Other white, White/ Black Caribbean, White/Black African,
White/ Asian, Other Mixed, Indian, Pakistani, Bangladeshi, Other Asian, Black Caribbean,
Black African, Other black, Chinese, Other Ethnic, Not Known.
7. Route to Diagnosis (for each diagnosis): Emergency Presentation, GP referral, Inpatient
Elective, Other Outpatient, Screening, Two Week Wait, Unknown.
8. Deprivation score: 1 (least deprived), 2, 3, 4, 5 (Most deprived).
In order to establish the incidence of anal cancer in women with genital cancers, data will
be requested on the total number of women/year (between 2001 and 2019), in England, aged
between 25-90+ years with a diagnosis of:
- Anal cancer
- Anal HSIL
- Vulvar cancer
- Vulvar HSIL
- Vaginal cancer
- Vaginal HSIL
- Cervical cancer
- Cervical HSIL
ICD-10 malignant neoplasm and carcinoma in-situ codes will be used to identify these
patients:
- Anal Cancer C21.0. C21.1, C21.8
- Cancer of the Vulva C51.0, C51.1, C51.2, C51.8, C51.9
- Cancer of the Vagina C52.
- Cancer of the Cervix Uteri C53.0, C53.1, C53.8, C53.9
- Anal HSIL D01.3
- Vulval HSIL D07.1
- Vaginal HSIL D07.2
- Cervical HSIL D06.0, D06.1, D06.7, D06.9
Primary Objective:
Establish the incidence of anal HSIL and cancer in women with genital HSILs and/cancers and
vice versa in England.
Secondary Objectives:
1. Asses the risk of anal HSIL and SCC in women with genital HSILs and/or SCC in England.
2. Investigate the sociodemographic risk profile of women developing multizonal anogenital
HPV driven high-risk pathologies.
3. Establish the timelines between the development of genital HSIL/SCC and anal HSIL/SCC.
Primary Outcome:
The incidence of anal HSIL and cancer in women with genital HSIL and/cancer in England
between 2001- 2019.
Secondary Outcomes:
1. The risk of anal HSIL and/or SCC in women with genital HSILs and/or SCC in England.
2. The relationship between the incidence of multizonal anogenital disease and specific
sociodemographic risk factors (ethnicity, age, social deprivation).
3. The amount of time in years and months between the diagnosis of genital HSIL/SCC and
anal HSIL/SCC.
Statistics and Data Analysis:
Data will be analysed using SPSS Statistics software. All outcomes extracted from the
database will be expressed in categorical fields; therefore, comparisons of outcomes will be
analysed using Chi squared or Fisher's Exact Tests. A statistically significant p value for
this analysis is defined as p < 0.05. Incidence will be calculated per 100,000 people per
year. Any missing data fields were classified as "unknown" within the database. Missing data
will not be excluded from the analysis and "unknown" variables are included with tables and
figures to prevent bias.
