Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis

Status: Open and recruiting at ICHT.

Type: Observational

Funder: European Commission

Sponsor: Imperial College of Science, Technology and Medicine

CI: Prof Michael Levin

IRAS-Number: 278651

CPMS-ID: 45537

Approval Date: 02 April 2020

Description:

The overall aim of DIAMONDS is to design new diagnostic tests that can tell quickly and accurately what illness a patient has when they come to hospital with common symptoms such as fever. This would help the right treatment to be given to the right patient, at the right time. This is called ‘personalised medicine’.

The diagnostic device is called ‘personalised medicine signature device’ (PMSD). There are four parts to DIAMONDS;

  1. DIAMONDS Search whose aim is to find RNA signatures in blood from patients with infectious and/or inflammatory conditions;
  2. Establishment of the European Diagnostic Transciptomic Library to enable analysis of molecular taxonomy of infectious and inflammatory disease which will be used as the basis for personalised diagnosis;
  3. Development and configuration of devices to rapidly detect gene transcripts required for PMSD and evaluation on improved patient diagnosis and treatment;
  4. Evaluation of performance of diagnostic devices in prospective recruitment of patients and controls in the DIAMONDS Pilot Demonstration.

The impact of the implementation of the devices will be also evaluated. This IRAS submission is for the first part – DIAMONDS Search – whose aim is to find RNA signatures in blood from a range of prospectively recruited patients with infectious and/or inflammatory conditions. We also recruit control patients for comparison of RNA transcripts. We will recruit at least 5000 patients (globally) and controls over 2½ years. We will also collect resource-use data on recruited patients and correlate the information with biomarker findings.

DIAMONDS Search will take place in hospitals within the European Union, UK, Switzerland as well as The Gambia and Asia. Our approach will be as ‘light touch’ and pragmatic as possible, to facilitate recruitment as comprehensively as possible, whilst ensuring the minimum impact on participants. Samples for research will be collected alongside routine clinical sampling up to three occasions during each hospital admission.