Purpose of the Research
Our overarching goal for this project is 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. Our R&D partner is Ludger and blood analysis will be performed at their labs in Oxfordshire, UK.
Glycosylation is one of the most essential processes occurring in the human body, contributing to its correct functioning. It is present on more than half of all proteins, which are the main structural and functional biomolecules in nature. Technically, glycosylation consists of the addition of individual sugar units to protein fragments, to build up long chains of sugar molecules (glycans), resulting in very specific and strictly defined structures. It is critical for a wide range of biological processes, as it regulates the interaction of the molecules, and cells they are attached to, with the surrounding environment. As such, glycans are involved in virtually every biological process in the human body, from fertilization and embryogenesis, through cell proliferation, differentiation, and development, to immunity and aging.
Glycosylation carries valuable information about the processes occurring inside the human body. However, many of the correlations between glycosylation and individuals’ health and lifestyle factors have not been studied before and remain undiscovered.
During this project, we will be also studying associations between different glycosylation features, abnormalities, and differences in blood plasma glycosylation profiles to better understand correlations between glycosylation patterns, immunofrailtiy, and lifestyle factors in young individuals.
We will be using our proprietary technology – GlyHealth, in vitro diagnostic platform to measures complex glycomics patterns in your blood samples. We will then apply our proprietary analytical models to calculate your glycomic indices and to define your Immunofrailty status.
This study will enable us to make one step further in the development of our biomarkers and immunofrality model, therefore, enhancing current healthcare for Inflammatory diseases.
We will review your application and as soon as it is approved the first blood collection will be sent to you
Three finger prick blood collection kits will be sent to you
Collect three small blood with three months interval and send to our labs
Monitor and share information about your lifestyle changes after receiving your first report
We will collect, preserve and analyse the following information as part of this research project: general information (e.g. date of birth, gender, ethnicity), health-related information provided by you as parr of health questionnaire (e.g. medical conditions, diseases), lifestyle information may be provided by you retrospectively or collected as part of this study (e.g. sleep patterns, movement/activity data) and your glycosylation analysis results (e.g. GHI and % of Gal Indices). Your name and contact information will NOT be subject of research but will be stored securely for the purpose of unique sample identification. Any other sensitive personal information (e.g. credit card details, used ID, passwords) will NOT be stored or analysed as part of research.
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 our research 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 may not benefit you directly, however 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 Index 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.
If you agree to this consent document, 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.
Your blood plasma sample 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.
Who Can I Contact in Case of Questions?
Principal Investigator: Dr Daniel I R Spencer
Organizations: Ludger Ltd and Avenna Ltd
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