NCT05702502 Assessing the Presence of CT-DNA in Lymphoma Associated HLH
| NCT ID | NCT05702502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nottingham University Hospitals NHS Trust |
| Condition | Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12 participants in total. It began in 2023-06-30 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: * 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 criteria: • Cause of HLH already known to be due to a non-malignant cause.
Frequently Asked Questions
Who can join the NCT05702502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05702502 currently recruiting?
Yes, NCT05702502 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nottingham University Hospitals NHS Trust to inquire about joining.
Where is the NCT05702502 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT05702502 clinical trial?
NCT05702502 is sponsored by Nottingham University Hospitals NHS Trust. The trial plans to enroll 12 participants.