Early Detection and Screening of Hematological Malignancies - SANGUINE (SANGUINE)

March 24, 2025 updated by: JaxBio Ltd

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

General criteria for all study populations:

  1. Male and female subjects ≥18 years of age
  2. 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:

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:

  1. First-degree relatives; AND /OR
  2. Elderly subjects ≥ 65 years of age.

Exclusion Criteria:

  1. Patients/subjects with current co-diagnosis of another type of cancer;
  2. 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;
  3. Patients with a diagnosis of acute promyelocytic leukemia (APL)
  4. Patients/subjects with active inflammatory autoimmune disease that requires treatment with immunosuppressive/ immunomodulation agents;
  5. Patients/subjects with known human immunodeficiency virus (HIV) positive;
  6. Patients/subjects with known active Hepatitis A/B/C or past hepatitis C;
  7. Subjects that are likely to be noncompliant with the protocol, or felt to be unsuitable by the investigator for any other reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

Other Names:
  • HemaChip
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.
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.

Other Names:
  • HemaChip
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.
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.

Other Names:
  • HemaChip
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.
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.

Other Names:
  • HemaChip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker discovery
Time Frame: 36 month
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
Time Frame: 36 month
Validating the discovery platform (HemaChip) as a diagnostic tool for various blood cancers.
36 month
Early detection for hematological malignancies
Time Frame: 36 month
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
Time Frame: 36 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JaxBio Ltd

Collaborators

Tel Aviv University
Tel-Aviv Sourasky Medical Center
University Hospital Olomouc
Vilnius University Hospital Santaros Klinikos
FORSCHUNGSZENTRUM FUR MEDIZINTECHNIK UND BIOTECHNOLOGIE
PREDICTBY RESEARCH AND CONSULTING S.L.
UAB ORIENTOS
EUROPEAN CANCER ORGANISATION
Predict * By
Faculty of Medicine and Dentistry, Palaky University Olomouc
National Kapodistrian University of Athens
JaxBio Technologies

Investigators

  • Study Chair: Yuval Prof. Ebenstein, PhD, Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SANGUINE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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