Refining animal research: The Animal Study Registry.
Ontology highlight
ABSTRACT:
SUBMITTER: Bert B
PROVIDER: S-EPMC6793840 | biostudies-literature | 2019 Oct
REPOSITORIES: biostudies-literature
Publications
Refining animal research: The Animal Study Registry.
Bert Bettina B Heinl Céline C Chmielewska Justyna J Schwarz Franziska F Grune Barbara B Hensel Andreas A Greiner Matthias M Schönfelder Gilbert G
PLoS biology 20191015 10
The Animal Study Registry (ASR; www.animalstudyregistry.org) was launched in January 2019 for preregistration of animal studies in order to increase transparency and reproducibility of bioscience research and to promote animal welfare. The registry is free of charge and is designed for exploratory and confirmatory studies within applied science as well as basic and preclinical research. The registration form helps scientists plan their study thoroughly by asking detailed questions concerning stu ...[more]
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Project description:Background and study aims
Lynch Syndrome (LS) is an inherited disorder that is associated with an increased risk of several cancers, particularly bowel cancer, as well as cancer of the womb. In the UK, there are only 6,000 known LS patients, however, it is estimated that there are about 176,000 undiagnosed cases. Given their high risk of bowel cancer, these patients require close monitoring, also known as ‘surveillance’, by colonoscopy - a thin tube with a camera on one end which is used to examine the bowel lining.
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In this study the researchers will develop an LS registry with multiple aims. It will be used to review and improve how LS patients are managed; it will provide data to better support the national screening programme's upcoming role in taking on and managing LS surveillance; and it will provide a unique resource to conduct and support future research into LS.
Who can participate:
LS patients who have previously taken part in the Cancer Prevention Project 3 (CaPP3) trial will be recruited from five sites in England over 9 months.
What does the study involve:
This small-scale initial study, known as a pilot study, will help to answer several important research questions around how LS patients are currently managed, as well as assisting with optimising the data collection process and functionality of the registry for both users and researchers.
Participation will involve completing and returning a baseline health questionnaire, followed by collecting surveillance data at the local hospital with additional data provided by NHS Digital. Data will be held on a secure and confidential database and in accordance with GDPR and Data Protection legislation. Further information will be available at the study website (https://lynchregistry.org.uk/) once the study is open to recruitment.
What are the possible risks and benefits of participating?
There are no risks of physical harm associated with taking part in this study. However, as the registry will be storing some personal information, there is a risk of a breach of confidentiality. The risks stemming from a data breach include; patient distress or loss of patient confidence and fraud by way of identity theft. To minimise the possibility of this occurring, several policies and procedures are in place to help protect participant information and to ensure that any personal information that could identify individuals remains strictly confidential. A data security policy is in place detailing precautions for safe operation such as encryption, access restrictions, security audits and secure software development practices. In the event that there is a breach of confidentiality, all participants will be notified.
There may not be an immediate direct benefit from joining the registry pilot study, but the information we get might help improve the treatment of people with Lynch Syndrome. As the national registry eventually becomes more established Lynch syndrome patients will benefit by being offered regular screening examinations, in line with the national guidelines. Additionally, the national registry will help to raise awareness of Lynch syndrome amongst clinical teams and promote future research projects and collaborations.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
April 2020 to March 2024
Who is funding the study?
1. Cancer Research UK
2. 40tude (UK)
Who is the main contact?
Prof. Amanda Cross
amanda.cross@imperial.ac.uk
| 2718278 | ecrin-mdr-crc