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RECRUITING
NCT05735704

Early Detection and Screening of Hematological Malignancies - SANGUINE

Sponsor: JaxBio Ltd

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, non-interventional controlled study to identify and characterize the epigenetic signatures for a set of hematological malignancies: Multiple myeloma (MM), pre-MM conditions \[smoldering MM (SMM) and monoclonal gammopathy of undetermined significance (MGUS)\], Hodgkin lymphoma (HL), diffuse large B cell lymphoma (DLBCL), Follicular lymphoma (FL), Marginal Zone lymphomas (MZL), acute myeloid leukemia (AML)\*, myelodysplastic syndrome (MDS), subjects at risk and control subjects with no malignant disease. \*Patients with a diagnosis of acute promyelocytic leukemia (APL) are not included

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2023-01-30

Completion Date

2027-01-31

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Blood sampling for HemaChip screening/diagnostic testing

Classification of a broad spectrum of blood cancers based on detection of epigenetic biomarkers from genomic DNA, cell-free (cf) DNA, exosomal DNA, RNA, and non-coding RNA. The identified biomarkers will include proteins, metabolites, and other characteristic biomolecules. Year 1: During the discovery phase, all tests will be conducted by JaxBio and TAU with the aid of technical service providers. At this stage, microarray measurements will be performed on a commercial platform that will be purchased from Agilent / Illumina. All reagents needed for the test will be either purchased or produced in-house. Years 2-3: Throughout the second phase of the project, a custom-targeted microarray, HemaChip will be developed and used for all tests. The HemaChip and custom reagents will be distributed to partners' labs and all tests will be conducted at the clinical sites. Additional validation tests will be conducted by JaxBio and TAU, as needed.

Locations (4)

Fakultni Nemocnice Olomouc (Fnol)

Olomouc, Czechia

National and Kapodistrian University of Athens (NKUA)

Athens, Greece

Tel-Aviv Sourasky Medical Center (TASMC)

Tel Aviv, Israel

Vilnus University Hospital Santaros Klinikos (VULSK)

Vilnius, Lithuania