Detecting cancer DNA in patients with severe blood disease
Liquid Biopsy for the Identification of Malignancy Associated Haemophagocytic Lymphohistiocytosis (HLH)
This study is testing if a blood test for cancer DNA can help doctors find lymphoma earlier in patients with a severe blood disease called HLH.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nottingham University Hospitals NHS Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Trial ID | NCT05702502 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify circulating tumor DNA (ctDNA) in patients diagnosed with Haemophagocytic Lymphohistiocytosis (HLH), a severe condition often associated with lymphoma. By analyzing blood samples from patients with HLH, the study seeks to determine if ctDNA can be used as a biomarker for earlier diagnosis of lymphoma. The research highlights the challenges in diagnosing lymphoma in HLH patients due to overlapping symptoms with severe sepsis, which can lead to delayed treatment and poor outcomes. The goal is to improve survival rates by facilitating quicker and more accurate diagnosis of underlying lymphomas.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have clinically confirmed HLH and have not received systemic anti-cancer therapy for more than 72 hours.
Not a fit: Patients whose HLH is already known to be caused by a non-malignant condition will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of lymphoma in patients with HLH, potentially improving survival rates.
How similar studies have performed: While the use of ctDNA in lymphoma diagnosis is being explored, this specific approach in the context of HLH is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nottingham, Nottinghamshire
- Nottingham Univeristy Hospitals NHS Trust — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.