Trial Title:
Anal Cancer Risk In Women
NCT ID:
NCT05835947
Condition:
Anal Cancer
Human Papilloma Virus
Anal Intraepithelial Neoplasia
Genital Neoplasm
Genital Cancer
Conditions: Official terms:
Neoplasms
Carcinoma in Situ
Papilloma
Anus Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Dual Pathology
Description:
Women with both genital HSIL/SCC and Anal HSIL/SCC
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Women in England affected by both an anal and a genital HSILs/SCCs between 2001-2019.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Women aged 25-90+ years of age.
- Women diagnosed with anal cancer and/or HSIL between 2001 and 2019.
- The anogenital cancer must be a squamous cell carcinoma.
- Women with a diagnosis of anal cancer and/or HSIL and:
1. vaginal cancer and/ or HSIL
2. vulvar cancer and/or HSIL
3. cervical cancer and/or HSIL
4. vaginal and vulvar cancer and/or HSIL
5. vaginal and cervical cancer and/or HSIL
6. vulvar and cervical cancer and/or HSIL
7. vaginal, cervical and vulvar cancer and/or HSIL
Exclusion Criteria:
- Men with a diagnosis of anal HSIL and/or SCC.
- Women aged outside of the 25-90+ years bracket.
- Women diagnosed with anal cancer or HSIL before 2001 and after 2019.
- Women with genital or anal cancer which is not a squamous cell carcinoma.
Gender:
Female
Minimum age:
25 Years
Maximum age:
100 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Imperial College London- Chelsea and Westminster NHS Foundation Trust
Address:
City:
London
Zip:
SW10 9NH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Micol Lupi
Phone:
020 3315 8000
Phone ext:
4469
Email:
m.lupi22@imperial.ac.uk
Contact backup:
Last name:
Christos Kontovounisios
Phone:
020 3315 8000
Phone ext:
4469
Email:
c.kontovounisios@imperial.ac.uk
Investigator:
Last name:
Christos Kontovounisios
Email:
Principal Investigator
Investigator:
Last name:
Paris Tekkis
Email:
Principal Investigator
Facility:
Name:
Imperial College London- Chelsea and Westminster NHS Foundation Trust
Address:
City:
London
Zip:
SW10 9NH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Micol Lupi
Phone:
020 3315 8000
Email:
m.lupi22@imperial.ac.uk
Start date:
September 1, 2022
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05835947
