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NCT06734624Not yet recruiting

The Microbiome in Blood Cancer and HLH

Using Blood and Stool Samples From Patients With Blood Cancer and/or Haemophagocytic Lymphohistiocytosis to Study the Influence of Host Microbial Factors on Toxicity and Survival

Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
750 (estimated)
First submitted
11 Nov 2024
Start date
1 Jan 2025
Primary completion date
31 Dec 2039
Lead sponsor
University of Nottingham
NCT number
NCT06734624

What you commit to

  • Study type: Observational
  • Planned participants: 750
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2039
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active communicable disease eg SARS-CoV-2, monkeypox.

Lab values

  • Known positive HIV, hepatitis B and/or hepatitis C serology (as laboratory not accredited to handle high-risk samples).

Who the study is looking for

  • Informed consent
  • Age 16-100 years
  • A blood cancer or clinically confirmed HLH by H-score criteria

Age in the registry: 16 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Nottingham
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.