- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05473325
Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY) (BRANCH-P)
Preclinical Drug Discovery Informed by Public Health: Initiating a Step-Change in the Development of New Human Models
Aperçu de l'étude
Statut
Les conditions
- La dépression
- Maladies cardiaques
- Maladies cardiovasculaires
- Infections à VIH
- Obésité
- Diabète
- Cancer
- Maladies rénales chroniques
- Arthrite
- Boulimie
- Maladie d'Alzheimer
- Cellulite
- Cirrhose
- Eczéma
- Ostéoporose
- Appendicite
- Bronchite
- Une maladie intestinale
- Goutte
- Maladie alcoolique du foie
- Grippe
- Taux de cholestérol élevé
- Allergies
- Indigestion
- Mononucléose
- Leucémie
- SIDA et infections
- Chest Infections
Description détaillée
The research project aims to gauge the efficacy of benchtop Nuclear Magnetic Resonance devices in a primary health care setting. The study design and methodology is as follows:
Typically, before a patient attends their routine standard of care blood test, they will speak with their local General Practitioner (GP) or a Registered Nurse (RN). At these visits, the medical professional will gauge the interest of the patient and test if they are eligible. If the patient is interested in becoming involved with research, and they are eligible for the study, they will be given a 'Study Information and Informed Consent Form' to read before their next visit. This allows for ample time to become fully informed on what the study entails, as well as to ask any questions they may have.
The 'Study Information and Informed Consent Form' document contains all information detailing: the purpose of the study, the significance of the research, and the patient's right to withdraw at any time (as in accordance with General Data Protection Regulations [GDPR] 2018), potential risks and benefits of taking part in the study and who to contact if the patient had any further questions to be asked.
At the patient's routine standard of care visit, they will present their signed and dated consent form to the medical professional taking the biological samples. If the patient loses their consent form before this visit, they will be given another to complete in full before any residual biological samples are taken. This will be counter-signed by the medical professional present at their visit. The patient will then be anonymised by being given a unique identifier in the form of a barcode. This barcode will be applied to the consent form, and the form will act as a linking document. The patient will only be referred by their unique identifier for the remainder of the study. This anonymisation of identifiable patient information (such as name, Date of Birth [DoB], etc.) extends to any data produced by analysing the patient's samples. The patient will keep a copy of the consent form for their own records, whilst the original document will be held by the research team to be stored on-site behind several layers of security. A copy of the consent form will also be uploaded onto the patients SystmOne profile. SystmOne is a clinical computer system used by medical professionals to log patient visits, review tests results and upload any new relevant data.
After sample collection, no further actions are required of the patient for the remainder of the study. The patient will be given a debriefing document thanking them for their contribution. Within this document there are contact details of the researchers involved and other contact telephone numbers to a variety of organisations and helplines specialising in emotional support, if the patient feels in any way affected by the study. The patient will also be offered the opportunity to be given a copy of their bio fluid spectral data should they be interested in this. This will be accompanied by explanatory notes.
The biological samples collected from the patient will go to two different locations: samples taken as part of the patient's routine standard of care will go to a local diagnostics lab where they will be tested on a variety of metrics. Residual biological samples will be processed and tested at the local Willows Health Near Patient Testing laboratory, before being frozen at -80oC.
The test results provided by the diagnostics lab will be uploaded to the patient's SystmOne account, where they will be scribed and used for the study, as outlined in the 'Study Information and Informed Consent Form' document. Results gathered from the Willows Health Near Patient Testing laboratory will also be uploaded to the patients SystmOne account and stored for later use within the study. The combination of these two sets of data will form the Near Patient Testing data set.
The residual biological samples frozen at Willows Health will then be transferred in batch format to Nottingham Trent University's (NTU's) benchtop Nuclear Magnetic Resonance device. They will then be thawed, prepared further and analysed using the benchtop Nuclear Magnetic Resonance device. The resultant spectra will be stored on the password protected device to form the benchtop Nuclear Magnetic Resonance data set. With both sets of data gathered (Near Patient Testing suite and benchtop Nuclear Magnetic Resonance spectra), a machine learning algorithm will cross-compare the data sets to 'teach' a program to 'read' the benchtop Nuclear Magnetic Resonance spectra and output data in the form of Near Patient Testing machines.
On average, ~42 patients attend the Willows Health Medical Centre for routine standard of care visits per week in which biological samples are collected for pathology lab testing. This equates to ~168 samples per month. With the sample collection window planned to take a year, this calculates to ~2016 potential participants being involved within the study. This is an estimated maximum, as not all patients who come for their annual review may not consent to the research study. Additionally, some religious events and holidays may limit the uptake of potential participants, for example: during Ramadan, although it is not strictly prohibited, blood tests may be avoided due to the weakening effect it may have. This, in conjunction with fasting, may dissuade potential participants from joining the study.
Given the substantial volumes of data required to 'train' software when utilising machine learning algorithms, the sample size needs to be large. This is imperative to produce accurate and reliable results from training and test sets for machine learning algorithms.
This research will result in several advantages for both clinical care and patients. For instance, efficient and rapid analysis of biological fluids will help to overcome the limitations associated with diagnosis of a variety of diseases such diabetes, chronic kidney disease, cancer and any other conditions that might go asymptomatic in the early stages. This work has the potential to pave the way for new clinical pathological techniques to support the early diagnosis of diseases.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Philippe B Wilson
- Numéro de téléphone: +44 07777688519
- E-mail: philippe.wilson@ntu.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Daniel JS Wolski
- Numéro de téléphone: +44 07776415044
- E-mail: daniel.wolski@nhs.net
Lieux d'étude
-
-
Leicestershire
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Leicester, Leicestershire, Royaume-Uni, LE5 4LJ
- Willows Medical Centre
-
Contact:
- Daniel JS Wolski
- Numéro de téléphone: +44 07776415044
- E-mail: daniel.wolski@nhs.net
-
Contact:
- Imran Kapasi
- Numéro de téléphone: +44 07428589207
- E-mail: imran.kapasi@nhs.net
-
Chercheur principal:
- Philippe B Wilson
-
Chercheur principal:
- Rishabh Prasad
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
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.
Exclusion Criteria:
If any of the exclusion criterion applies, the participant must not be included in the study:
- Participants who are unable to provide consent due to incapacity.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Signal to Noise
Délai: PhD study duration (Final Submission Date: 22 June 2025)
|
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)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Philippe B Wilson, Professor at Nottingham Trent University
- Chercheur principal: Rishabh Prasad, Partner at Willows Health
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles induits chimiquement
- Maladies du système digestif
- Processus pathologiques
- Maladies métaboliques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles liés à l'alcool
- Troubles liés à une substance
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies urologiques
- Inflammation
- Troubles neurocognitifs
- Attributs de la maladie
- Signes et symptômes digestifs
- Maladies gastro-intestinales
- Maladies bronchiques
- Insuffisance rénale
- Maladies musculo-squelettiques
- Maladies du tissu conjonctif
- Gastro-entérite
- Maladies neurodégénératives
- Maladies intestinales
- Maladies de la peau, infectieuses
- Maladies pulmonaires obstructives
- Hyperphagie
- Maladies osseuses
- Troubles du métabolisme lipidique
- Démence
- Tauopathies
- Suppuration
- Hyperlipidémies
- Dyslipidémies
- Maladies osseuses métaboliques
- Maladies cæcales
- Infections intra-abdominales
- Troubles induits par l'alcool
- Maladies du foie
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladies rénales
- Insuffisance rénale chronique
- Dyspepsie
- Infections
- Maladies transmissibles
- Boulimie
- Maladie d'Alzheimer
- Cellulite
- Hypercholestérolémie
- Ostéoporose
- Appendicite
- Bronchite
- Maladies du foie, alcoolique
Autres numéros d'identification d'étude
- CRT00442
- 315046 (Autre identifiant: IRAS Application Project ID)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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