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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: Yes
Enrollment: 3000
Sponsor: JaxBio Ltd

Location: Fakultni Nemocnice Olomouc (Fnol) Olomouc

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05735704). StuddyBuddy aggregates publicly available trial information.