GenOMICC study - Looking at DNA of patients with severe illness and injury to find the genes that cause some people to become very unwell and be admitted to intensive care

Genetics Of susceptibility and Mortality In Critical Care (GenOMICC)

Registry ID
ISRCTN16993428
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Accord (United Kingdom)
Enrollment
100000
Start date
2016-01-01
Completion date
2029-08-31
Last update
2026-08-17

Conditions

Summary

This study aims to identify genetic predisposition to specific syndromes of critical illness and outbreaks or exposures of public health interest. This includes susceptibility to life-threatening infections, and susceptibility to adverse outcomes, including mortality, following the onset of organ failure due to sepsis or sterile injury

Detailed description

Current interventions as of 24/10/2025: Current protocol dated 23/10/2024 (Version 5): Participants will be asked to consent by signing a consent form. A single blood sample will be taken (roughly 4 ml) to get a DNA sample. If a participant is unable to give a blood sample for any reason, a sample of saliva may be taken instead in some circumstances. For those participants who have been discharged from the hospital, a research nurse will arrange a home visit at a convenient time, or a saliva sample kit can be sent if preferred. _____ Previous interventions as of 15/04/2024: People with severe illness (such as COVID-19, influenza, sepsis, and other causes of critical illness), and healthy volunteers (for comparison) will be approached to participate in the study. Participants will be asked to consent by signing a consent form. A single blood sample will be taken (roughly 4 ml) to get a DNA sample. If a participant is unable to give a blood sample for any reason, a sample of saliva may be taken instead in some circumstances. For those participants who have been discharged from the hospital, a research nurse will arrange a home visit at a convenient time, or a saliva sample kit can be sent if preferred. _____ Previous interventions: People with severe illness (such as COVID-19, influenza, sepsis, and other causes of critical illness), and healthy volunteers (for comparison) will be approached to participate in the study. Participants will be asked to consent by signing a consent form. A single blood sample will be taken (9 ml; roughly 2 teaspoons) to get a DNA sample. If a participant is unable to give a blood sample for any reason, a sample of saliva may be taken instead in some circumstances. For those participants who have been discharged from the hospital, a research nurse will arrange a home visit at a convenient time, or a saliva sample kit can be sent if preferred.

Interventions

Inclusion criteria

Current key inclusion criteria as of 24/10/2025: The entry criteria below are approved for use in the UK: 23 October 2024 v5.0 Patients will be recruited who: 1. Are deemed, in the view of the treating clinician, to require continuous cardiovascular or respiratory monitoring or any organ support 2. Provide appropriate consent or assent 3. Whose primary reason for admission is one of the following primary diagnoses: -Critical illness caused by any confirmed or suspected infection OR -Common non-infectious critical illness syndromes: --Pancreatitis of any aetiology --Full thickness burns covering >20% of body surface area --Rare non-infectious critical illness syndromes: -Haemophagocytic syndrome --Still’s disease --Heat stroke --Radiation poisoning -Suspected reactions to therapeutic agents: This includes cell therapies, gene therapy, CAR T-cell therapy, investigational drugs or vaccines in the view of the treating clinician. For example: --Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), or SJS-TEN overlap to any therapeutic agent --Cell therapy associated reaction --Acute hepatitis associated with gene therapy in any age group -Confirmed or suspected presence of an emerging critical illness syndrome, such as: --unexplained or idiosyncratic presentations of acute organ injury in the view of the treating clinician confirmed or suspected exposures of public health interest in the view of the study leadership in consultation with public health agencies. An updated description of these syndromes will be maintained by the central study team on our website. -Non-infectious critical illness syndromes in children or babies: --Preterm birth (babies born <32 weeks postmenstrual age) -Acute seronegative or unexplained hepatitis in children: --patients under the age of 16 with elevated liver transaminase (ALT > 500 iU/L or AST > 500 iU/L), not due to other diagnoses such as hepatitis viruses A-E, autoimmune hepatitis, or poisoning -Organ Support. Examples

Exclusion criteria

Current key exclusion criteria as of 24/10/2025: Bone marrow transplant recipients _____ Previous participant exclusion criteria as of 25/01/2023: There are no exclusion criteria. All consenting patients can be recruited. _____ Previous participant exclusion criteria: Exclusion criteria do not apply to COVID-19. All consenting COVID-19 patients will be included. For all inclusion categories apart from COVID-19, patients who are functionally limited by any comorbid illness (such as frailty, heart failure, chronic obstructive pulmonary disease (COPD), or reduced exercise tolerance of any cause) or have significant immunosuppression (such as cancer chemotherapy or acquired immune deficiency syndrome) will be excluded from this study.

Locations

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