Early Detection and Screening of Hematological Malignancies - SANGUINE
SANGUINE
1 other identifier
observational
3,000
4 countries
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedMarch 26, 2025
March 1, 2024
3 years
January 31, 2023
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Biomarker discovery
define a set of differential epigenetic biomarkers that uniquely identify the following conditions: MM, pre-MM conditions (SMM and MGUS), HL, aggressive NHL (DLBCL, HGL, FL and MZL transformed to large cell lymphoma), FL, MZL, de novo AML, secondary AML, MDS and healthy subjects.
36 month
Validation of Hemachip
Validating the discovery platform (HemaChip) as a diagnostic tool for various blood cancers.
36 month
Early detection for hematological malignancies
Towards early detection - Patients, at risk of relapse tested periodically to evaluate early detection capability of the HemaChip.
36 month
population screening for hematological malignancies
Towards population screening - evaluate the sensitivity and specificity for screening in populations at risk for developing the investigated cancers: (i) elderly (\>65 years old) at high risk to develop MM; (ii) first degree relatives of the conditions described above.
36 month
Study Arms (4)
Patients with Hematological Malignancies - Discovery stage
The first stage (discovery phase) will include at least 30 patients from each of the following groups: MM, pre-MM conditions (SMM and MGUS), HL, aggressive NHL (DLBCL, FL, MZL, AML, MDS. NOTE: Patients diagnosed with DLBCL that is transformed from FL or MZL, and patients diagnosed with AML secondary to MDS or MPN, that were treated for their primary disease (FL/MZL/MDS/MPN) prior to study enrollment, are eligible. Patients with a diagnosis of acute promyelocytic leukemia (APL) will not be included. For patients, it is expected, after signing the informed consent, that the serial samplings will be performed during the disease follow-up according to the standard clinical practice and/or recommended schedule and disease assessment plan.
Patients with Hematological Malignancies - Second stage
In the second stage, at least 250 patients with MM, 250 patients with NHL, and at least 100 patients with each of the remaining hematological malignancies mentioned above will be tested. Out of these patients, AML, lymphoma, and MM patients will be followed up on at the clinical sites. Periodic sampling will be defined according to disease type and progression rate. Blood and plasma samples will be stored at clinical sites until relapse diagnosis. At this stage, blood samples will be analyzed retrospectively on the HemaChip. The screening, enrollment, and sample collection can begin in the first stage of the trial, to allow a maximum follow-up period for at-risk subjects as part of the study and to meet the recruitment goals.
Subjects at risk of developing MM / lymphoproliferative disorder - Third stage
The last stage consists of screening of a larger group of subjects at risk of developing MM / lymphoproliferative disorder. This stage will include 400 elderly patients (\>65 years old) and 500 first-degree relatives of patients (and in particular siblings). The screening, enrollment, and sample collection can begin in the first stage of the trial, in order to meet the recruitment goals.
Control subjects with no malignant disease- Discovery stage
Control subjects with no malignant disease that serve as controls are expected to donate blood a single time. Following this donation, their participation will end.
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.
Eligibility Criteria
Adult subjects with hematological malignancies: Multiple myeloma (MM), pre-MM conditions \[smoldering MM (SMM) and monoclonal gammopathy of undetermined significance (MGUS)\], Hodgkin lymphoma (HL), non-Hodgkin aggressive lymphoma NHL \[diffuse large B cell lymphoma (DLBCL), FL, MZL, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), subjects at risk and control subjects with no malignant disease.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JaxBio Ltdlead
- Tel Aviv Universitycollaborator
- FORSCHUNGSZENTRUM FUR MEDIZINTECHNIK UND BIOTECHNOLOGIEcollaborator
- University Hospital Olomouccollaborator
- Faculty of Medicine and Dentistry, Palaky University Olomouccollaborator
- Vilnius University Hospital Santaros Klinikoscollaborator
- PREDICTBY RESEARCH AND CONSULTING S.L.collaborator
- National Kapodistrian University of Athenscollaborator
- Tel-Aviv Sourasky Medical Centercollaborator
- UAB ORIENTOScollaborator
- EUROPEAN CANCER ORGANISATIONcollaborator
- Predict * Bycollaborator
- JaxBio Technologiescollaborator
Study Sites (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
Biospecimen
Blood and bone marrow samples are collected and stored for 15 years from the end of the study
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yuval Prof. Ebenstein, PhD
Tel Aviv University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 21, 2023
Study Start
January 30, 2023
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
March 26, 2025
Record last verified: 2024-03