Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)

NCT05473325 | Unknown

• 2 other identifiers: CRT00442315046
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This research programme seeks to combine the resources of NHS primary care, with the leading spectroscopic work in low-magnetic fields of the Wilson Group (Nottingham Trent University) to demonstrate the potential for benchtop Nuclear Magnetic Resonance (NMR) spectroscopy in human clinical pathology. This is an instrument assessment study for point of care viability which will also result in enhanced patient care (pending their consent) in blood screenings and metabolic health data.

Conditions

Diabetes; Chronic Kidney Diseases; Cancer; Bowel Disease; Cardiovascular Diseases; Mononucleosis; Flu; Heart Diseases; HIV Infections; AIDS and Infections; Bulimia; Chest Infections; Arthritis; Leukaemia; Alcoholic Liver Disease; Allergies; Alzheimer Disease; Appendicitis; Eczema; Bronchitis; Cellulitis; Cirrhosis; Depression; Gout; High Cholesterol; Indigestion; Obesity; Osteoporosis

Keywords

Low-Field Nuclear Magnetic Resonance; Multi-component Analysis; Primary Healthcare; Clinical Pathology

Outcome Measures

Primary Outcomes (1)

• Signal to Noise

  An \>0.97 (or 97%) area under the receiver operating characteristic (AUROC) of benchtop Nuclear Magnetic Resonance versus current Point of Care (POC) testing sensitivity/specificity in conditional classification of samples.

  PhD study duration (Final Submission Date: 22 June 2025)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohort consists of those who are visiting the Willows Medical Centre for their routine standard of care visits. Patients visiting this primary care site consist of a range of ages, ethnicities and gender.

You may qualify if:

• All participants must satisfy ALL the following criteria at study entry:
• A male or female aged equal to or greater than 18 years of age.
• Participants who, in the opinion of the investigator, can and will comply with requirements of the study procedures (e.g. Attend routine standard of care testing clinics, agree to share routine standard of care test results for the purposes of research, etc.).
• Participants who are able to provide written informed consent.

You may not qualify if:

• Participants who are unable to provide consent due to incapacity.

Sponsors & Collaborators

• Willows Health: lead
• Nottingham Trent University: collaborator

Study Sites (1)

Willows Medical Centre

Leicester, Leicestershire, LE5 4LJ, United Kingdom

Location

Related Publications (1)

• Percival BC, Grootveld M, Gibson M, Osman Y, Molinari M, Jafari F, Sahota T, Martin M, Casanova F, Mather ML, Edgar M, Masania J, Wilson PB. Low-Field, Benchtop NMR Spectroscopy as a Potential Tool for Point-of-Care Diagnostics of Metabolic Conditions: Validation, Protocols and Computational Models. High Throughput. 2018 Dec 27;8(1):2. doi: 10.3390/ht8010002.

  PMID: 30591692 BACKGROUND

Related Links

• Willows Health Homepage
• Nottingham Trent University Homepage

Biospecimen

Retention: SAMPLES WITH DNA

Residual samples will be collected from patients visiting the Willows Health Medical Centre for their routine standard of care checkups. Residual biological samples will be comprised of whole blood which will be processed into serum, analysed on local Near Patient Testing machines and frozen at -80'C. They will then be transported to Nottingham Trent University, thawed and analysed on the benchtop Nuclear Magnetic Resonance device.

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic; Neoplasms; Intestinal Diseases; Cardiovascular Diseases; Infectious Mononucleosis; Influenza, Human; Heart Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Infections; Bulimia; Arthritis; Leukemia; Liver Diseases, Alcoholic; Hypersensitivity; Alzheimer Disease; Appendicitis; Eczema; Bronchitis; Cellulitis; Fibrosis; Depression; Gout; Hypercholesterolemia; Dyspepsia; Obesity; Osteoporosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Immunologic Deficiency Syndromes; Slow Virus Diseases; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Neoplasms by Histologic Type; Liver Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Intraabdominal Infections; Gastroenteritis; Cecal Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Inflammation; Behavioral Symptoms; Behavior; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Bone Diseases, Metabolic; Bone Diseases

Study Officials

• Philippe B Wilson

  Professor at Nottingham Trent University

  PRINCIPAL INVESTIGATOR

• Rishabh Prasad

  Partner at Willows Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe B Wilson

CONTACT

07777688519; philippe.wilson@ntu.ac.uk

Daniel JS Wolski

CONTACT

07776415044; daniel.wolski@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 22, 2025
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

GB (1)