About this trial
The bacteria and viruses in the bowel (gut microbiota; GM) have powerful effects on the immune system. GM changes are seen in patients with auto-immune diseases, where the immune system attacks normal tissues, and cancer, and for those with some forms of blood cancer, and appears to affect both responses to, and side-effects of treatment. The investigators want to examine the GM and the associated small molecules (metabolites) in adults with different forms of blood cancer, particularly those undergoing immunotherapy, those with have newly diagnosed follicular lymphoma, and also those with a severe hyperinflammatory disorder which causes problems similar to sepsis called Haemophagocytic lymphohistiocytosis (HLH), which is also often caused by an underlying lymphoma. The investigators want to collect blood and stool samples from patients and use the results of tests already performed in the NHS as well as recording how well patients responded to treatment. The samples will be used to identify novel targets within the GM and associated metabolites which contribute to side effects of, or response to immunotherapy, or are responsible for causing HLH which can be targeted to make treatment better tolerated. For patients with newly diagnosed indolent lymphoma the aim is to see if there are differences which may account for patients needing early or late treatment, or no treatment ever.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent
Age 16-100 years
A blood cancer or clinically confirmed HLH by H-score criteria
Disqualifiers
Known positive HIV, hepatitis B and/or hepatitis C serology (as laboratory not accredited to handle high-risk samples).
Active communicable disease eg SARS-CoV-2, monkeypox.
Trial population
Participants will be recruited from haematology clinics and wards within Nottingham University Hospitals NHS Trust.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To collect blood and stool samples from patients with blood cancer and/or HLH to enable the study of the influence of the host immune system and gut microbiota on toxicity and survival.
The study aims to assess characteristic baseline signatures and/or dynamic changes within the immune system and gut microbiome/metabolome predicting toxicity, progression and survival adult patients with blood cancer or HLH. The study is exploratory.
Sponsors and contacts
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University of Nottingham
Lead sponsor
Nottingham University Hospitals NHS Trust
Collaborator
This trial is not recruiting at the moment. You can still explore other options: