Trial Title:
Early Detection and Screening of Hematological Malignancies - SANGUINE
NCT ID:
NCT05735704
Condition:
Hematologic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
Multiple myeloma
Pre-MM conditions
Hodgkin lymphoma
Non-Hodgkin aggressive lymphoma & diffuse large B cell lymphoma
High grade lymphoma
Follicular lymphoma
Marginal zone lymphoma, transformed to large cell lymphoma]
acute myeloid leukemia
Myelodysplastic syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Blood sampling for HemaChip screening/diagnostic testing
Description:
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.
Arm group label:
Control subjects with no malignant disease- Discovery stage
Arm group label:
Patients with Hematological Malignancies - Discovery stage
Arm group label:
Patients with Hematological Malignancies - Second stage
Arm group label:
subjects at risk of developing MM / lymphoproliferative disorder - Third stage
Other name:
HemaChip
Intervention type:
Diagnostic Test
Intervention name:
Bone marrow sampling
Description:
as part of the discovery stage, bone marrow samples will be obtained at Tel-Aviv Sourasky
Medical Center (TASMC) from up to 50 MM patients and up to 50 AML patients that undergo
bone marrow aspiration as part of the standard care procedure. Additionally, up to 50
bone marrow samples will be taken from healthy volunteers that will undergo hip or knee
replacement surgery.
Arm group label:
Control subjects with no malignant disease- Discovery stage
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), non-Hodgkin aggressive lymphoma
NHL [diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), Marginal Zone
Lymphoma (MZL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and subjects
at risk and control subjects with no malignant disease.
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, aggressive NHL (DLBCL, HGL,
FL, and MZL transformed to large cell lymphoma), FL, MZL, AML, MDS, and control subjects
with no malignant disease.
In the second stage, at least 250 patients with MM and 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
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, in order to allow a maximum follow-up period for at-risk subjects as part of
the study and to meet the recruitment goals.
The last stage consists of the screening of a larger group of subjects with a high risk
of blood cancer. This stage will include three populations: up to 1000 follow-up patients
from each blood cancer: AML, lymphoma, and MM, up to 600 elderly patients (>65 years old)
at risk of developing MM, and up to 400 first-degree relatives of patients (and in
particular siblings). In order to allow a maximum follow-up period for at-risk subjects
as part of the study, and to meet the recruitment goals, the screening, and enrollment
can begin in the first stage of the trial.
The last stage consists of screening 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 allow a maximum follow-up period for at-risk subjects as part of the study
and 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 (see section 9.1), (serious) AEs related to study procedures, treatment for the
disease, disease response and survival status will be collected (as applicable).
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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, aggressive NHL (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, that were treated for their primary disease
(FL/MZL/MDS/MPN) prior to study enrollment, are eligible.
For subjects at risk for developing the investigated hematological malignancies:
1. First-degree relatives;
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/subjects with active inflammatory autoimmune disease that requires
treatment with immunosuppressive/ immunomodulation agents;
4. Patients/subjects with known human immunodeficiency virus (HIV) positive;
5. Patients/subjects with known active Hepatitis A/B/C or past hepatitis C;
6. Subjects that are likely to be noncompliant with the protocol, or felt to be
unsuitable by the investigator for any other reason.
Gender:
All
Gender based:
Yes
Gender description:
older then 18 year old
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fakultni Nemocnice Olomouc (Fno)
Address:
City:
Olomouc
Country:
Czechia
Status:
Recruiting
Facility:
Name:
8. Ethniko Kai Kapodistriako Panepistimio Athinon (Nkua)
Address:
City:
Atene
Country:
Greece
Status:
Recruiting
Facility:
Name:
Tel-Aviv Sourasky Medical Center (TASMC)
Address:
City:
Tel Aviv
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Miri Ne'eman, MD
Email:
Yakov.miri@gmail.com
Facility:
Name:
Santaros Klinikos
Address:
City:
Vilnius
Country:
Lithuania
Status:
Recruiting
Contact:
Last name:
Karolis Sablauskas, MD
Email:
Karolis.Sablauskas@santa.lt
Start date:
January 30, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
JaxBio Ltd
Agency class:
Industry
Collaborator:
Agency:
Tel Aviv University
Agency class:
Other
Collaborator:
Agency:
FORSCHUNGSZENTRUM FUR MEDIZINTECHNIK UND BIOTECHNOLOGIE
Agency class:
Other
Collaborator:
Agency:
UNIVERZITA PALACKEHO V OLOMOUCI
Agency class:
Other
Collaborator:
Agency:
FAKULTNI NEMOCNICE OLOMOUC
Agency class:
Other
Collaborator:
Agency:
Vilnius University Hospital Santaros Klinikos
Agency class:
Other
Collaborator:
Agency:
PREDICTBY RESEARCH AND CONSULTING S.L.
Agency class:
Other
Collaborator:
Agency:
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Agency class:
Other
Collaborator:
Agency:
Tel Aviv Medical Center
Agency class:
Other
Collaborator:
Agency:
UAB ORIENTOS
Agency class:
Other
Source:
JaxBio Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05735704
