RecruitingNCT05735704

Early Detection and Screening of Hematological Malignancies - SANGUINE

Sponsor

JaxBio Ltd

Enrollment

3,000 participants

Start Date

Jan 30, 2023

Study Type

OBSERVATIONAL

Conditions

Hematologic Malignancy

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The SANGUINE study aims to develop better tools for early detection of blood cancers — including multiple myeloma, leukaemia, lymphoma, and myelodysplastic syndromes (MDS) — before they become advanced. Researchers will collect blood samples from newly diagnosed patients (before treatment) and from people at elevated risk, such as close relatives and adults over 65. The goal is to find early warning signals in the blood that could allow earlier diagnosis and treatment. **You may be eligible if...** - You are 18 or older and able to give written informed consent - You have been newly diagnosed with one of the listed blood cancers (multiple myeloma, MGUS, smouldering myeloma, Hodgkin lymphoma, DLBCL, follicular lymphoma, marginal zone lymphoma, AML, or MDS) and have NOT yet started treatment, OR - You are a first-degree relative of someone with one of these cancers, OR - You are 65 or older (considered higher risk for these cancers) **You may NOT be eligible if...** - You have another active cancer (diagnosed within the last 2 years) - You have acute promyelocytic leukaemia (APL) - You have active HIV, hepatitis A, B, or C - You have an active autoimmune disease requiring immune-suppressing drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBlood 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.