Healthy Volunteers Blood Collection
Research type
Research Study
Full title
Collection of blood and blood products from healthy volunteers for biomarker/method development purposes
IRAS ID
241751
Contact name
Richard Marais
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The proposed research is focused on blood-borne biomarkers. A biomarker is a measurable characteristic or biological molecule present in the blood, other body fluids or tissues, which reflect a process or condition and could be used to monitor certain diseases. Biomarkers are increasingly used in the management of cancer
patients.
In potential biomarker studies it is important to determine the levels of the biomarker under investigation in a healthy individual. This will allow the determination whether or not changes in the biomarker of interest would indicate a pathological condition, or a response to treatment. The principal research question is: “is
there a difference in levels of the biomarker of interest in a healthy population versus a cancer patient population?”A collection of blood and blood products from a cohort of healthy volunteers represents an invaluable resource for research purposes. It allows the identification and validation of new biomarkers and the development of new detection methods. Measurement of a biomarker of interest in a healthy population provides a reference on normal levels in the absence of cancer and allows comparison with levels detected in cancer patients. As a consequence, the study of a candidate biomarker in a healthy population provides a mean for evaluating treatment responses in cancer patients receiving therapy.
In addition, the analysis of a biomarker of interest in a healthy population is performed for method validation studies. The analysis of the biomarker under investigation in healthy volunteers is used to determine that a method is effective and generates reproducible results.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0468
Date of REC Opinion
29 Jun 2018
REC opinion
Favourable Opinion