Early Detection and Screening of Hematological Malignancies - SANGUINE

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

Conditions

• Hematologic Malignancy

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.

Sponsors & Collaborators

• Tel Aviv University

  collaborator OTHER

• FORSCHUNGSZENTRUM FUR MEDIZINTECHNIK UND BIOTECHNOLOGIE

  collaborator UNKNOWN

• University Hospital Olomouc

  collaborator OTHER

• Faculty of Medicine and Dentistry, Palaky University Olomouc

  collaborator UNKNOWN

• Vilnius University Hospital Santaros Klinikos

  collaborator OTHER

• PREDICTBY RESEARCH AND CONSULTING S.L.

  collaborator UNKNOWN

• National Kapodistrian University of Athens

  collaborator UNKNOWN

• Tel-Aviv Sourasky Medical Center

  collaborator OTHER_GOV

• UAB ORIENTOS

  collaborator UNKNOWN

• EUROPEAN CANCER ORGANISATION

  collaborator UNKNOWN

• Predict * By

  collaborator UNKNOWN

• JaxBio Technologies

  collaborator UNKNOWN

• JaxBio Ltd

  lead INDUSTRY

Principal Investigators

• Yuval Prof. Ebenstein, PhD · Tel Aviv University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-30

Primary Completion

2026-01-31

Completion

2026-01-31

Countries

• Czechia
• Greece
• Israel
• Lithuania

Study Locations