Prospective Validation of the OHI Index

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMeir Medical Center

About this trial

Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) \> 3,900 U/mL and ferritin \>1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with hematologic malignancies

At least 18 years old

Disqualifiers

Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)

Trial population

Male and females with new diagnosis/transformation/reactivation of hematologic malignancies

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: OHI+ patients
Group B: OHI- patients

Trial outcomes

Primary outcomes

1

To assess 365 days mortality of OHI+ and OHI- patients

The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients

Time frame
Mortality rate one year from OHI assessment

Secondary outcomes

1

To determine the incidence of OHI+ patients in our cohort

The investigators will assess the incidence of OHI+ within our cohort (OHI+/total patients enrolled)

Time frame
The investigators will assess the incidence after three years of enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meir Medical Center

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Collaborator

Rabin Medical Center

Collaborator

Sheba Medical Center

Collaborator

Schneider Children's Medical Center, Israel

Collaborator