An improved index for diagnosis and mortality prediction in malignancy-associated hemophagocytic lymphohistiocytosis.
Adi Zoref-Lorenz, Jun Murakami, Liron Hofstetter...
https://pubmed.ncbi.nlm.nih.gov/34780598Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID05882175
A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index
Led by Meir Medical Center · Updated on 2025-05-13
300
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Meir Medical Center
Lead Sponsor
C
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating hemophagocytic lymphohistiocytosis (HLH) that occurs in patients with blood cancers, focusing on a new diagnostic and prognostic tool called the Optimized HLH Inflammatory (OHI) index. This index combines elevated levels of soluble CD25 (sCD25) and ferritin to better understand HLH's occurrence and outcomes in these patients, whose survival rates are generally low. The study aims to clarify the incidence and prognosis of HLH as defined by the OHI index in an unselected patient group. The study enrolls adults newly diagnosed with or transformed hematologic malignancies. Participants are grouped based on their OHI index status—those with both high sCD25 and ferritin levels (OHI+) and those without this combined elevation (OHI-). Researchers will observe and monitor these patients over time without providing specific investigational treatments, as this is an observational study. Participants will be followed until the study's conclusion, with survival monitored for one year after OHI assessment. The main outcome is to measure mortality rates at 365 days for both OHI+ and OHI- groups. Additionally, the study will determine how common OHI+ status is among the cohort after three years of enrollment. Patients may undergo clinical evaluations and laboratory tests as part of routine care during their participation.
CONDITIONS
Brief Title
Prospective Validation of the OHI Index
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients with hematologic malignancies
- At least 18 years old
You will not qualify if you...
- Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 3 years
Participants with hematologic malignancies are observed to assess their prognosis and survival over time.
Trial Site Locations
Total: 2 locations
1
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
2
Rabin Medical Center
Petah Tikva, Israel, 49100
Actively Recruiting
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Research Team
A
Adi Zoref Lorenz, MD
N
Noa Rabinowicz, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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