Early Detection and Screening of Hematological Malignancies - SANGUINE

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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:

⁃ 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.

Locations
Other Locations
Greece
National and Kapodistrian University of Athens (NKUA)
RECRUITING
Athens
Israel
Tel-Aviv Sourasky Medical Center (TASMC)
RECRUITING
Tel Aviv
Lithuania
Vilnus University Hospital Santaros Klinikos (VULSK)
RECRUITING
Vilnius
Contact Information
Primary
Helena Grinberg-Rashi, PhD
lenagrin@gmail.com
+31615636666
Backup
Yael Michaeli, PhD
yaelmi@jaxbio.com
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 3000
Treatments
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.
Sponsors
Collaborators: Tel-Aviv Sourasky Medical Center, JaxBio Technologies, Vilnius University Hospital Santaros Klinikos, Predict * By, EUROPEAN CANCER ORGANISATION, Tel Aviv University, PREDICTBY RESEARCH AND CONSULTING S.L., FORSCHUNGSZENTRUM FUR MEDIZINTECHNIK UND BIOTECHNOLOGIE, University Hospital Olomouc, National Kapodistrian University of Athens, Faculty of Medicine and Dentistry, Palaky University Olomouc, UAB ORIENTOS
Leads: JaxBio Ltd

This content was sourced from clinicaltrials.gov