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Trial Title:
Prospective Validation of the OHI Index
NCT ID:
NCT05882175
Condition:
HLH
Hemophagocytic Lymphohistiocytoses
Hemophagocytic Syndrome
Hematologic Malignancy
Hematologic Neoplasms
Conditions: Official terms:
Hematologic Neoplasms
Lymphohistiocytosis, Hemophagocytic
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies
(HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). We
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.
Detailed description:
The investigators will enroll patients with new/transformed hematologic malignancies. We
will follow the patients until the end of the study, report their survival at one year
and examine their prognosis.
Criteria for eligibility:
Study pop:
Male and females with new diagnosis/transformation/reactivation of hematologic
malignancies
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients with hematologic malignancies
- At least 18 years old
Exclusion Criteria:
- Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last
month)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Meir Medical Center
Address:
City:
Kfar Saba
Zip:
4428164
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Uri Abadi, MD
Phone:
+972 537482629
Email:
uri.abadi@clalit.org.il
Facility:
Name:
Rabin Medical Center
Address:
City:
Petach Tikva
Zip:
49100
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Ronit Gurion, MD
Phone:
+972 504065336
Email:
ronitg@clalit.org.il
Start date:
March 3, 2021
Completion date:
March 3, 2026
Lead sponsor:
Agency:
Meir Medical Center
Agency class:
Other
Collaborator:
Agency:
Children's Hospital Medical Center, Cincinnati
Agency class:
Other
Collaborator:
Agency:
Rabin Medical Center
Agency class:
Other
Collaborator:
Agency:
Sheba Medical Center
Agency class:
Other
Collaborator:
Agency:
Schneider Children's Medical Center, Israel
Agency class:
Other
Source:
Meir Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05882175
