Purpose of the Research
AvLB represents an IBD patient’s life-course health biography told in longitudinal data. This data is complex and messy. It is typically heterogeneous, high dimensional, high volume, incomplete, skewed, and partially corrupted. AvLB’s job is to gather and encode that data, tidy it up, and annotate it, ready for pattern analysis by ProDroma-IBD.
AvLB aims to provide a well-stocked Data Lake for personalised IBD care. It will deal with data from two broad classes of health factors:
- Health determinants – these are factors such as food that influence health.
- Health metrics – these are factors such as heart rate variability that measure health status.
Our overarching goal is to develop core AvLB data structures and algorithms to cleanse, curate, and annotate datasets on patients with inflammatory bowel disease (IBD). The cleansed data would then be ready to be analysed by ProDroma-IBD, a novel AI system we are developing to predict the likely future health trajectories of IBD patients and their responses to anti-inflammatory treatments.
During this study, we will test Emoiré pattern analysis algorithms developed to provide insights into patterns of health determinants that impact the health trajectory of individuals living with IBD. This will include ‘red’ patterns that worsen IBD flares and ‘blue’ patterns that improve the individual’s gut health.
This study will help to further translate our novel glycan biomarkers which can be used by individuals and clinicians as a prodromal signal for various inflammatory conditions. This is to enable a precision medicine approach to prevent and treat inflammatory diseases, including IBD. Our R&D partner is Ludger and blood analysis will be performed at their labs at the Culham Science Centre in Oxfordshire, UK.
To analyse your blood samples we will be using our proprietary technology – GlyHealth. This is an in vitro diagnostic (IVD) platform that analyses biomolecular patterns in blood (specifically quantitative glycomics signals) that correlate with the progression of general and cID-specific inflammatory processes. We will then apply our proprietary analytical models to calculate your various glycomics indices. These include GlyHealth-IBD, which measures glycomics patterns that correlate with IBD-specific chronic inflammatory processes.
GlyHealth-IBD is our prognostic and predictive biomarker for inflammatory bowel disease (IBD). GlyHealth-IBD is at the TRL-6 development stage. GlyHealth-IBD is being co-developed by Avenna and Ludger which are sister companies based at the Culham Science Centre in Oxfordshire. Our TRL-4 and TRL-5 studies were performed in collaboration with the Translational Gastroenterology Unit (TGU) at the University of Oxford and showed that GlyHealth-IBD greatly outperforms current serological and faecal biomarkers for prognosis and prediction of IBD.
The terms ‘glycomic profiles’ and ‘glycosylation’ for GlyHealth refer to patterns of glycans that are attached to immune system proteins in blood. Glycans are complex biomolecules that modify the structures and functions of over half the proteins encoded by your body’s DNA. Glycans are now known to play critical roles in virtually every biological process in the human body, from fertilization and embryogenesis, through cell proliferation, differentiation, and development, to immunity and aging.
The importance of glycans in human health and disease was recognised by the awarding of a Nobel Prize in 2022 to Professor Carolyn Bertozzi for her work on glycans and how they affect diseases such as cancer, inflammation, and viral infections such as COVID-19.
- Read and sign this consent form
- Download the SANNO App and createyour profile by filling in questionnaire. The app is available worldwide on both, Apple Store and Play Store.
- You will track your symptoms, food, movement, sleep, and Bristol scale stool form via this app and automatically share data with researchers.
- In addition you will have your own private portal where you can upload your health information such asprevious Test (blood tests, endoscopies, stool test, genetic tests, etc).
- You will collect two small blood samples every three months and send them back to our labs.
- In addition to free assessments you will also receive a special gift from Avenna’ team.
- We will review your application and as soon as it is approved the first blood collection kit will be sent to your address.
- You will receive an email with your personal folder where you can upload your health data for us to analyse and give you insights.
- You will start monitoring and keeping track of your daily habits which may affect your disease course: food, movement, sleep, stress and share them on a monthly basis. Sanno App will enable an automatic upload of your data. Some other apps such as Samsung health app and apple health app will require more manual upload to your personal folder in Box
- You will need to collect two small blood samples every three months and post them to our labs
We will collect, preserve and analyse the following information as part of this research study:
General information (e.g. date of birth, gender, ethnicity, occupation and postal address – where you will be receiving the blood collection kit). Patient-supplied Clinical Health Metric Data (including endoscopy images, serological and faecal biomarker results, inflammation markers). Patient-supplied Omics Profiles (including genomics, and longitudinal GlyHealth-IBD glycomics, epigenetic, gut microbiome, metabolomics, and proteomics profiles). Clinical Health Determinant Data (including anti-inflammatory drug regimes and other therapies). Other Patient-Supplied Data (including digital biomarkers, e.g., symptoms-tracking information from apps such as Sanno and Viocare , lifestyle information including data on food, movement, and sleep). These datasets cover the initial set of health determinants and health factors that we believe could be most useful for patients and their medics.
Your name and contact information will be stored securely for the purpose of unique sample identification but will not be used in the study. Also, no other sensitive personal information will collected from you.
Your glycosylation analysis results along with the information provided by you (self-reported information) will be used for research purposes – which includes discovery of new traits and correlations between glycosylation profiles and health and chronic inflammation statuses. Our discoveries may be published in scientific journals or disseminated to the scientific community in other ways (e.g. presentations and talks during scientific events), as well as used as marketing material. In such cases, anonymised information, and information combined with other people’s results will be made public, and your personal information will remain private.
There are clinical methods for measuring acute inflammation in patients known as CRP (C-reactive protein). We would like to see if there is correlation between chronic inflammation as found by the glycan tests and acute inflammation as found by the CRP test. For the CRP measurement: C-reactive protein will be measured using a high sensitivity enzyme linked immunosorbent assay (ELISA) acquired from Invitrogen and compared against internationally recognised determinations of CRP levels representative of patients with non, minor and major chronic inflammation levels. To gain CRP levels we will use the same blood samples that are collected using the Lancet puncture method.
Benefits and Risks of Participation
The main goal of this study is to make meaningful scientific contributions in the field of precision medicine. By qualifying our customers to participate directly in the study, we enable them to contribute to the success of the project. This project is intended to assist us and other researchers to better understand the glycan features associated with health and wellbeing, as well as aging and disease to determine novel biomarkers. Participating in this project you may benefit from insights in your current health data as well as it is possible that our discoveries will contribute to expanded health assessment services in the future. The more information contributed to the project, the better the potential results could be, and better clinical tools can be developed and integrated into the healthcare ecosystem for IDs. Additionally, if Ludger or Avenna publish the study results in peer-reviewed journals, there will be added benefits for the wider research community. There is no additional financial cost to you, nor additional effort from your side for allowing the information from this analysis to be used in the project. The blood sample you provide will be analysed to provide the GlyHealth Indexes to you regardless of whether or not you decide to participate in the project. Based on the results of this study, Avenna may develop intellectual property and/or commercialise products and services. In such cases, you will not receive any financial compensation. We will own the results of the project and any subsequent publication of the results.
Your test results may reveal information about certain health conditions and predispositions, however, there are no physical risks for providing a blood sample and having your sample and information used in this project. While our discoveries and the self-reported information may be shared through scientific publication or within the research community in generalised form, this will not contain any personal information or the information that permits identification of you, such as your name and contact details. Also, research project results will not be communicated by us directly to you or any physician.
We work towards protecting your personal information. However, data can be stolen in the unlikely event of an incidental security breach, which may reveal your results associated with your personal information to the general public. This can happen whether or not you decide to participate in the research. However, we would like to assure you that we have strong data security policies and comply with industry standards for data security to minimise the possibility of a breach. Our data protection practices are detailed under the ‘Data Confidentiality’ section.
There may also be additional risks to participation that are currently unforeseeable.
Your personal information, your GlyHealth results, and the information obtained from this research will be stored electronically in the United Kingdom, with all the data being securely backed up to an online server to avoid data loss. We use a range of physical, technical, and administrative procedures and follow industry-standard protocols to protect the privacy of the information. Access to our databases and data center is restricted by passwords, pass cards, and encrypted Internet connections, and all the servers have firewall protection in place. Transfer of personal information is protected by encryption.
Access to personal information (such as your name and contact details) will be restricted to specifically authorised individuals closely working on the research project. Similarly, any document containing your information and any sample provided by you will be identified with a code and not your name, to limit the number of individuals having access to your personal data. Any personal information, or any information that would allow identification of you as an individual (direct identifiers), will not be disclosed externally. When we collaborate with external third parties as part of the project, these parties will only have access to pooled information from which direct identifiers have been removed. We will never purposely release any personal information without asking for and receiving your explicit authorization to do so, except as required by law.
Your identity and the information you shared will not be disclosed and your confidentiality as a participant in this study will remain secure. Subsequent uses of records and data will be subject to standard data use policies which protect the anonymity of individuals and institutions.
If you agree to this consent document, Avenna and Ludger can use the information you have provided, along with the results from the analysis, for research that may be published in scientific journals or disseminated to the scientific community in other ways (e.g. presentations and talks during scientific events). In such cases, your identity along with your direct identifiers will not be disclosed by us in any case and your privacy will be protected.
Avenna and Ludger have engaged a Data Processor (Sanno) to undertake some of the processing on our behalf. This will include provision of an App to collect data through the study and sending biomarkers to your home. This will involve them having access to your personal data. Sanno have been engaged through a contract that ensures that they will only process data on our instructions. They may also process personal data for the purposes of ensuring that the app is working effectively and improving it. You can access their privacy notices at www.sanno.health.
Your blood plasma samples will be stored in our labs in the United Kingdom. Your sample will not be labeled with your name or other directly identifying information. Instead, it will be identified with a code. The list that matches the code with your name and information will be stored separately from your sample. Your sample will be kept indefinitely unless you ask the researchers to destroy it.
Participation in this project is purely voluntary. At any time, you may choose to withdraw our right to use some or all the information you have provided by sending a request to firstname.lastname@example.org. We will cease using the information you have provided for the project and any future studies promptly after receipt of your request. There will be no penalty to you, and you will continue to be able to use our services as before. Any research using your information that has already begun, studies that have been performed completely, and any study results or findings that have been published prior to this date cannot be reversed, undone, or withdrawn.
In addition, the research study can be terminated at our discretion without your consent. Your personal information will be kept private even after the project is terminated or the data you provide is no longer in use.
Project lead: Nina Skoytchenko Email: email@example.com
PPI lead: Cindy Weiss Email: firstname.lastname@example.org
If you have any general questions or concerns about the research study, or if you have a question about subjects’ rights, please contact us via email or post:
Culham Science Centre
Oxfordshire, OX14 3EB, UK