NCT05835947

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

April 19, 2023

Last Update Submit

April 19, 2023

Conditions

Anal CancerHuman Papilloma VirusAnal Intraepithelial NeoplasiaGenital NeoplasmGenital Cancer

Outcome Measures

Primary Outcomes (1)

  • The incidence of anal HSIL and cancer in women with genital HSIL and/cancer in England

    as above

    2001- 2019

Secondary Outcomes (3)

  • he risk of anal HSIL and/or SCC in women with genital HSILs and/or SCC in England

    2001-2019

  • The relationship between the incidence of multizonal anogenital disease and specific sociodemographic risk factors.

    2001-2019

  • The amount of time in years and months between the diagnosis of genital HSIL/SCC and anal HSIL/SCC

    2001-2019

Interventions

Dual PathologyOTHER

Women with both genital HSIL/SCC and Anal HSIL/SCC

Eligibility Criteria

Age25 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women in England affected by both an anal and a genital HSILs/SCCs between 2001-2019.

You may qualify if:

  • 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:
  • vaginal cancer and/ or HSIL
  • vulvar cancer and/or HSIL
  • cervical cancer and/or HSIL
  • vaginal and vulvar cancer and/or HSIL
  • vaginal and cervical cancer and/or HSIL
  • vulvar and cervical cancer and/or HSIL
  • vaginal, cervical and vulvar cancer and/or HSIL

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imperial College London- Chelsea and Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

RECRUITING

Imperial College London- Chelsea and Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2023

First Posted

April 28, 2023

Study Start

September 1, 2022

Primary Completion

January 1, 2024

Study Completion

October 1, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Request to NHS digital is for de-personalised data. Researchers will not have access to individual participant data.

Locations

GB(2)