← Back to all trials
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.
Source: ClinicalTrials.gov (NCT05735704). StuddyBuddy aggregates publicly available trial information.