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Recruiting
NCT05735704
Early Detection and Screening of Hematological Malignancies - SANGUINE
Conditions: Hematologic Malignancy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 6000
Sponsor: JaxBio Ltd
Location: Czechia
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), high-grade lymphoma (HGL), follicular lymphoma (FL) and marginal zone lymphoma (MZL) transformed to large cell lymphoma], FL, MZL, de novo acute myeloid leukemia (AML), secondary AML, myelodysplastic syndrome (MDS) and healthy subjects.
Eligibility Criteria
Inclusion Criteria:General criteria for all study populations:Male and female subjects ≥18 years of ageAbility to understand and willingness to sign a written informed consent document.For Patients with blood cancers: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, HGL, FL, and MZL transformed to large cell lymphoma), FL, MZL, de novo AML, secondary AML, MDS that did not yet undergo any treatment or surgery.NOTE: Patients with transformed FL or MZL and patients with secondary AML that were treated for the primary disease prior to study enrollment are eligible.For Healthy subjects:First-degree relatives, spouses, and/or escorts of patients;Elderly subjects - ≥ 65 years of age.Exclusion Criteria: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 active inflammatory autoimmune disease, treated or untreated with immunosuppressive/ immunomodulation agents;Patients/subjects with known human immunodeficiency virus (HIV) positive;Subjects that are likely to be noncompliant with the protocol, or felt to be unsuitable by the investigator for any other reason.
Source: ClinicalTrials.gov (NCT05735704). StuddyBuddy aggregates publicly available trial information.