RecruitingNCT05702502

Assessing the Presence of CT-DNA in Lymphoma Associated HLH

Liquid Biopsy for the Identification of Malignancy Associated Haemophagocytic Lymphohistiocytosis (HLH)


Sponsor

Nottingham University Hospitals NHS Trust

Enrollment

12 participants

Start Date

Jun 30, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Haemophagocytic lymphohistiocytosis (HLH) is a rare life-threatening blood disease which causes severe inflammation with symptoms similar to severe sepsis. It is hard to diagnose. The most common cause of HLH in adults is lymphoma (blood cancer). Outcomes for adults with HLH and cancer are serious, and most die after days or weeks because they have been diagnosed or treated too late. It is likely that many cases where patients died of HLH with no underlying cause actually had cancer. Recently it has been found that patients with certain types of lymphoma have DNA which comes directly from their cancer (circulating tumour DNA; ctDNA). Aggressive lymphomas release a lot of ctDNA which can be detected in the blood of patients. This study will look for ctDNA in patients with HLH, and see if it is possible to use it to diagnose lymphoma earlier. Patients will provide a small additional blood sample for analysis. Diagnosing lymphoma more rapidly would mean more people could get the correct treatment for the lymphoma which has caused their HLH. They could receive the correct treatment sooner. Earlier diagnosis and treatment could improve survival for these patients.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Informed consent.
  • Age ≥18 years.
  • Clinically confirmed HLH.
  • High dose steroids and/or systemic anti-cancer therapy (SACT) for \<72 hours for the current episode of HLH (anakinra is not considered SACT). Prior steroid use \>14 days at the time of consent is permitted.
  • Patients with recurrent HLH may be included.
  • Patients already known to have underlying lymphoma, or have relapsed lymphoma may be included.

Exclusion Criteria1

  • • Cause of HLH already known to be due to a non-malignant cause.

Locations(1)

Nottingham Univeristy Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

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NCT05702502


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