Multinational Anal Squamous Cell Carcinoma Registry and Audit (mASCARA)https://www.chelwest.nhs.uk/about-us/research-innovation-and-quality-improvement-riqi/research-development/research-and-care/multinational-anal-squamous-cell-carcinoma-registry-and-audit-mascarahttps://www.chelwest.nhs.uk/++resource++plone-logo.svg
Multinational Anal Squamous Cell Carcinoma Registry and Audit (mASCARA)
Information for researchers
Introduction
Anal Squamous Cell Carcinoma (SCC) is an uncommon cancer with an incidence rate between 1 and 2 per 100,000 per year. The incidence of anal SCC is increasing rapidly, with an overall 63% increase in incidence rate of anal SCC in the UK since the 1990s. However, there is much discrepancy in best surgical practice for the treatment and prevention of anal SCC.
As anal SCC is a rare cancer it is difficult to gain sufficient patient numbers with enough statistical power to be able to provide evidence-based conclusions on best practice.
Although generic cancer databases such as Cancer Outcomes and Services Dataset (COSD) in the UK and the National Cancer Database (NCDB) in the USA exist they are limited to the data streams that are available to them. Both cannot link, for example, to HIV status or outcomes related anal high-grade squamous intraepithelial lesion (HSIL), the precursor to SCC. Neither can they report treatment regimens and recurrence rates.
mASCARA
The secure web-based platform called mASCARA has been accessible since May 2019. It is GDPR compliant and has received ethical approval from the UK's Research and Ethics Committee, a specialised GDPR database. While data is completely anonymised to the study group, it is pseudonymised to the submitting direct care teams (so that the direct care team can update outcomes like survival and recurrence over time).
Method
We are requesting the submission of retrospective anal SCC or HSIL patients as well as the prospective recruitment of patients with newly diagnosed with anal SCC or HSIL.
Any patient diagnosed with anal SCC/HSIL before 15/01/2024 is defined as a retrospective patient and will not need to be consented to be included in mASCARA.
However, prospective patients will need to give their informed consent prior to their inclusion in mASCARA. A prospective patient is defined as any person diagnosed with anal SCC or HSIL after 15/01/2024. An example consent form and patient information leaflet has been provided within the study documents.
HSIL will be defined as patients with histology specimens classified as:
AIN2
AIN3
Moderate anal intraepithelial neoplasia
Severe anal intraepithelial neoplasia
HSIL (high grade squamous intraepithelial lesion)
Once registered to take part, local research and information governance approval will need to be completed at the new clinical site, a data sharing agreement between Imperial College London and the site needs to be signed.
Inclusion criteria
Any patient over 18 years old, with or without HIV, with a histologically confirmed diagnosis of high grade Anal high-grade squamous intraepithelial lesion or Intraepithelial Neoplasia or Squamous Cell Carcinoma.
Exclusion criteria
Patient under the age of 18 years
Prospective patient (diagnosed after 15/01/2024) that refuses informed consent
Prospective patient (diagnosed after 15/01/2024) that does not have the capacity to consent to be take part
Patients with histology other than Squamous Cell Carcinoma
Primary objectives
Investigate demographic risk factors of patients with anal SCC
Determine risk factors for anal squamous intraepithelial lesions (SIL) progression to SCC
Investigate best treatment for patients with multifocal low-grade disease
Compare end outcomes of different anal SCC and SIL management guidelines from different centres
We have created a research database called mASCARA (Multinational Anal Squamous Cell Carcinoma Registry and Audit) for patients with anal squamous cell carcinoma (SCC) and anal squamous intraepithelial lesions (SIL). We would like to invite you to take part. We want to emphasise that this is entirely voluntary, and your decision will not affect your care in any way. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and decide whether you would like to take part. Thank you for reading this.
What is the purpose of the study?
We create databases of rare cancers such as anal squamous cell carcinomas so that we can study them in greater depth in larger patient numbers. It is difficult for us to produce high quality research for rare cancers unless we can recruit and study many patients. As anal squamous cell carcinoma is rare, it is difficult to study in large numbers unless research teams collaborate with each other. We hope that including your data, along with other patients, as well as collaborating with other research teams internationally that we may be able to answer important research questions and improve care.
Why am I being invited to take part?
You have been invited to take part because you have recently been diagnosed with anal squamous cell carcinoma or a high-grade squamous intraepithelial lesion.
Do I have to take part?
It is up to you whether you decide to take part. If you do, you will be given this information sheet to keep and be asked to sign a consent form. You are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time or a decision not to take part will not affect the standard of care you receive.
If you agree to take part, we will review your patient case notes from Chelsea and Westminster Hospital NHS Foundation Trust and request access to your notes from our sexual health database if you have previously had high resolution anoscopy screening. Your data will then be collected, anonymised and included in our study.
If, during the research, you wish to opt out of the study or have your data deleted, we will identify your data and remove it. It is possible that your data at the time of your request may already be downloaded to be analysed. Once analysis is underway your data will be anonymous and impossible to identify therefore we will be unable to exclude you from research that is already started. For research that has not yet started we will, on your request, remove your data.
If you decide to take part, we will ask you to sign a consent form. All the information which is collected about you during the research will be kept strictly confidential. Any information about you which leaves the hospital will be fully anonymised. All research activities will use anonymised data only.
Will my taking part in this study be kept confidential?
Every piece of information gathered about you for the study will be treated with the utmost confidentiality. Not long after you agree to be a part of the study, the data will be gathered. Any personal data that you provide to the hospital will be anonymised and will only be used in a manner approved by the research ethics committee, making it impossible to identify you from it. Only the individuals on your immediate healthcare team will have access to and be able to identify you personally based on the information provided in this information sheet. An outside IT contractor with experience in managing healthcare datasets will host the database. These same confidentiality requirements will apply to the outside contractor as well.
What will happen to the results of the research study?
Results will be collated and analysed. Data from this study will be presented at national or international conferences and written up for publication. Our results may be used to support other ethically approved research on the topic of anal HSIL and cancer in the future and may be shared anonymously with other researchers worldwide. If you would like a summary of the results when available, please inform the doctor/ investigator.
Who is organising and funding the research?
This project is registered with Imperial College London. The Red Trouser Day Charity is funding this research. None of the team members are receiving any financial incentives for conducting this research.
Who has reviewed the study?
The East Midlands Derby Research Ethics Committee has reviewed this study and given their approval. The study will be conducted in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions.
