Clinical trial NCT05735704: Early Detection and Screening of Hematological Malignancies - SANGUINE
Official title: Early Detection and Screening of Hematological Malignancies - SANGUINE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Malignancy
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
Lead sponsor: JaxBio Ltd
Sponsor class: INDUSTRY
Collaborators: name: Tel Aviv University
name: FORSCHUNGSZENTRUM FUR MEDIZINTECHNIK UND BIOTECHNOLOGIE
name: University Hospital Olomouc
name: Faculty of Medicine and Dentistry, Palaky University Olomouc
name: Vilnius University Hospital Santaros Klinikos
name: PREDICTBY RESEARCH AND CONSULTING S.L.
name: National Kapodistrian University of Athens
name: Tel-Aviv Sourasky Medical Center
name: UAB ORIENTOS
name: EUROPEAN CANCER ORGANISATION
name: Predict * By
name: JaxBio Technologies
First posted: 2023-02-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarker discovery
timeFrame: 36 month
measure: Validation of Hemachip
timeFrame: 36 month
measure: Early detection for hematological malignancies
timeFrame: 36 month
measure: population screening for hematological malignancies
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc (Fnol)
city: Atene
country: Greece
facility: National and Kapodistrian University of Athens (NKUA)
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center (TASMC)
city: Vilnius
country: Lithuania
facility: Vilnus University Hospital Santaros Klinikos (VULSK)
Study officials:
affiliation: Tel Aviv University
name: Yuval Prof. Ebenstein, PhD
role: STUDY_CHAIR
References: