Hematologic MalignancySANGUINENCT05735704
Early Detection and Screening of Hematological Malignancies - SANGUINE
An observational study of Hematologic Malignancy, run by JaxBio Ltd at 4 sites in 4 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Blood sampling for HemaChip screening/diagnostic testing
- How many people
- 3,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 30 Jan 2023to 31 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
- 1. 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Yael Michaeli, PhD contact
4 sites in 4 countries
Czechia1 site, 1 recruiting
- Recruiting
Fakultni Nemocnice Olomouc (Fnol)
Olomouc
Tomáš Papajík, Prof., MD, tomas.papajik@fnol.cz
Greece1 site, 1 recruiting
- Recruiting
National and Kapodistrian University of Athens (NKUA)
Athens
Efstathios Kastritis, Prof., MD, ekastritis@med.uoa.gr
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center (TASMC)
Tel Aviv
Miri Neaman, MD, Yakov.miri@gmail.com
Lithuania1 site, 1 recruiting
- Recruiting
Vilnus University Hospital Santaros Klinikos (VULSK)
Vilnius
Karolis Sablauskas, MD, Karolis.Sablauskas@santa.lt
About this study
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
Read the detailed description
Subjects will be screened for eligibility and then, after signing an Informed Consent Form, the first peripheral blood sample will be obtained.
Periodical blood samples will be obtained from the participants. Relapse patients will have their retrospective blood samples analyzed to identify early signs of disease.
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, DLBCL, FL, MZL, AML, MDS, and control subjects with no malignant disease.
In the second stage, at least 250 patients with MM 250 patients with NHL, at least 100 patients with each of the remaining hematological malignancies mentioned above, and control subjects with no malignant disease will be tested. Out of these patients, AML, lymphoma and MM patients will be followed up at the clinical sites. Periodic sampling will be defined according to disease type and progression rate. Blood and plasma samples will be stored in the clinical sites until relapse diagnosis. At this stage, blood samples will be analyzed retrospectively on the HemaChip. The screening, enrollment, and blood collection can begin in the first stage of the trial, to allow a maximum follow-up period, as part of the study, and to meet the recruitment goals.
The last stage consists of the 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, to allow a maximum period for at-risk subjects cohort to meet the recruitment goals.
In all stages, the age and sex-matched subgroups will be considered and matched.
During the follow-up period, demographic and baseline parameters including sex, age, race, height and weight, medical history, smoking status, details of initial diagnosis and treatment history, concomitant medications as well as adverse events (AEs) of special interest, (serious) AEs related to study procedures, treatment for the disease, disease response and survival status will be collected (as applicable).
- Conditions
- Hematologic Malignancy
- Being tested
- Blood sampling for HemaChip screening/diagnostic testing
- Keywords
- Multiple myeloma, Pre-MM conditions, Hodgkin Lymphoma, Non-Hodgkin aggressive lymphoma, High Grade Lymphoma, Follicular Lymphoma, Marginal zone lymphoma, Acute Myeloid Leukemia, Myelodysplastic syndrome, Diffuse large B cell lymphoma
- Medical subject headings
- Hematologic Neoplasms, Multiple Myeloma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for HemaChip screening/diagnostic testingDiagnostic test
Also called HemaChip
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood sampling for HemaChip screening/diagnostic testing | |
| 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. Receives: Diagnostic Test: Blood sampling for HemaChip screening/diagnostic testing | |
| 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. Receives: Diagnostic Test: Blood sampling for HemaChip screening/diagnostic testing | |
| 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. Receives: Diagnostic Test: Blood sampling for HemaChip screening/diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 month
Validation of Hemachip
Validating the discovery platform (HemaChip) as a diagnostic tool for various blood cancers.
Measured: 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.
Measured: 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.
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 Jan 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JaxBio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel Aviv University, FORSCHUNGSZENTRUM FUR MEDIZINTECHNIK UND BIOTECHNOLOGIE, University Hospital Olomouc, Faculty of Medicine and Dentistry, Palaky University Olomouc, Vilnius University Hospital Santaros Klinikos, PredictBy Research and Consulting, S.L, National and Kapodistrian University of Athens, Tel-Aviv Sourasky Medical Center, UAB ORIENTOS, EUROPEAN CANCER ORGANISATION, Predict * By, JaxBio Technologies
- Responsible party
- Sponsor
- Investigators
- Yuval Prof. Ebenstein, PhD, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735704
- Sponsor's protocol ID
- SANGUINE
- Acronym
- SANGUINE
- Status last verified
- Aug 2026
- First submitted
- 31 Jan 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No