- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Philippe B Wilson
- 전화번호: +44 07777688519
- 이메일: philippe.wilson@ntu.ac.uk
연구 연락처 백업
- 이름: Daniel JS Wolski
- 전화번호: +44 07776415044
- 이메일: daniel.wolski@nhs.net
연구 장소
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Leicestershire
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Leicester, Leicestershire, 영국, LE5 4LJ
- Willows Medical Centre
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연락하다:
- Daniel JS Wolski
- 전화번호: +44 07776415044
- 이메일: daniel.wolski@nhs.net
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연락하다:
- Imran Kapasi
- 전화번호: +44 07428589207
- 이메일: imran.kapasi@nhs.net
-
수석 연구원:
- Philippe B Wilson
-
수석 연구원:
- Rishabh Prasad
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Signal to Noise
기간: 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)
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Philippe B Wilson, Professor at Nottingham Trent University
- 수석 연구원: Rishabh Prasad, Partner at Willows Health
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 정신 질환
- 화학적으로 유발된 장애
- 소화기계 질환
- 병리학적 과정
- 대사 질환
- 뇌 질환
- 중추신경계 질환
- 신경계 질환
- 알코올 관련 장애
- 물질 관련 장애
- 호흡기 감염
- 호흡기 질환
- 폐 질환
- 비뇨기과 질환
- 염증
- 신경인지 장애
- 질병 속성
- 징후 및 증상, 소화기
- 위장병
- 기관지 질환
- 신부전
- 근골격계 질환
- 결합 조직 질환
- 위장염
- 신경퇴행성 질환
- 장 질환
- 피부 질환, 전염병
- 폐 질환, 폐쇄성
- 과식증
- 뼈 질환
- 지질 대사 장애
- 백치
- 타우병증
- 진정
- 고지혈증
- 이상지질혈증
- 뼈 질환, 대사
- 맹장 질환
- 복강 내 감염
- 알코올 유발 장애
- 간 질환
- 심장 질환
- 심혈관 질환
- 신장 질환
- 신부전, 만성
- 소화불량
- 감염
- 전염병
- 폭식증
- 알츠하이머병
- 봉와직염
- 고콜레스테롤혈증
- 골다공증
- 충수염
- 기관지염
- 간 질환, 알코올
기타 연구 ID 번호
- CRT00442
- 315046 (기타 식별자: IRAS Application Project ID)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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