Early Detection and Screening of Hematological Malignancies - SANGUINE
JaxBio Ltd
3,000 participants
Jan 30, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria10
- General criteria for all study populations:
- Male and female subjects ≥18 years of age
- Ability to understand and willingness to sign a written informed consent document.
- For Patients with hematological malignancies:
- \. Patients who have been diagnosed, have measurable disease, and/or are being monitored/followed up due to one of the following conditions: MM, pre-MM conditions (SMM and MGUS), HL, DLBCL, FL, MZL, AML, MDS that did not yet undergo any treatment.
- NOTE:
- Patients diagnosed with DLBCL that is transformed from FL or MZL, and patients diagnosed with AML secondary to MDS or MPN, who were treated for their primary disease (FL/MZL/MDS/MPN) before study enrollment, are eligible.
- For subjects at risk for developing the investigated hematological malignancies:
- First-degree relatives; AND /OR
- Elderly subjects ≥ 65 years of age.
Exclusion Criteria7
- Patients/subjects with current co-diagnosis of another type of cancer;
- Patients/subjects with a known active or prior cancer (other than defined as study population), occurring within the last 2 years (even if considered to be in complete remission). Patients/subjects with non- melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection;
- Patients with a diagnosis of acute promyelocytic leukemia (APL)
- Patients/subjects with active inflammatory autoimmune disease that requires treatment with immunosuppressive/ immunomodulation agents;
- Patients/subjects with known human immunodeficiency virus (HIV) positive;
- Patients/subjects with known active Hepatitis A/B/C or past hepatitis C;
- Subjects that are likely to be noncompliant with the protocol, or felt to be unsuitable by the investigator for any other reason.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05735704