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Taking people in IsraelNo phase

Blood Test Study to Detect Early Blood Cancers

Tests a blood sample screen for blood cancers in adults, including people at risk.

Key facts

Who runs it
JaxBio Ltd
Where
Tel Aviv, IsraelSee the siteAlso in 3 other countries, 3 sites
Trial code
Registry title
Early Detection and Screening of Hematological Malignancies - SANGUINE
Status
Recruiting
People taking part
3,000 people, planned
Started
30 Jan 2023
Expected to end
31 Jan 2027
Type of study
Observational, 4 groups
Treatments tested
  • Blood sampling for HemaChip screening/diagnostic testing
Record updated
15 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain blood cancers or early blood conditions who have not yet been treated, adults at risk, and people with no cancer as controls.

Age
18 years or older.
Sex
Women and men can join.
Disease stage
Multiple myeloma, smoldering multiple myeloma, MGUS, Hodgkin lymphoma, diffuse large B cell lymphoma, follicular lymphoma, marginal zone lymphoma, acute myeloid leukemia or myelodysplastic syndrome, diagnosed or being followed. People at risk are first-degree relatives or people aged 65 or older.
Earlier treatment
Patients must not have had any treatment yet for the condition. Exceptions: DLBCL changed from follicular or marginal zone lymphoma, and AML following MDS or MPN, treated for the first disease.

Main reasons for not taking part

  • Another current cancer, or another cancer within the last 2 years (skin cancer without melanoma or carcinoma in situ is fine if fully removed)
  • Acute promyelocytic leukemia (APL)
  • Active autoimmune disease needing immune-suppressing treatment
  • Known HIV-positive
  • Known active hepatitis A, B or C, or past hepatitis C

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients/subjects with active inflammatory autoimmune disease that requires treatment with immunosuppressive/ immunomodulation agents
  • 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/subjects with known human immunodeficiency virus (HIV) positive
  • Patients/subjects with known active Hepatitis A/B/C or past hepatitis C
  • Patients with a diagnosis of acute promyelocytic leukemia (APL)
  • Subjects that are likely to be noncompliant with the protocol, or felt to be unsuitable by the investigator for any other reason

Where in Israel

Also in 3 other countries, 3 sites

  • Tel Aviv Sourasky Medical Center - TASMCTel Aviv, IsraelContact: Miri Neaman, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

*Patients with a diagnosis of acute promyelocytic leukemia (APL) are not included

The 4 groups in the trial

  • 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: Blood sampling for HemaChip screening/diagnostic testing

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Early Detection and Screening of Hematological Malignancies - SANGUINE
Plain-language title
Blood Test Study to Detect Early Blood CancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 October 2026