NCT05735704 Early Detection and Screening of Hematological Malignancies - SANGUINE
| NCT ID | NCT05735704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JaxBio Ltd |
| Condition | Hematologic Malignancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-01-30 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-01-30 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Yuval Prof. Ebenstein, PhD
STUDY CHAIR
Tel Aviv University
Frequently Asked Questions
Who can join the NCT05735704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05735704 currently recruiting?
Yes, NCT05735704 is actively recruiting participants. Contact the research team at lenagrin@gmail.com for enrollment information.
Where is the NCT05735704 trial being conducted?
This trial is being conducted at Olomouc, Czechia, Athens, Greece, Tel Aviv, Israel, Vilnius, Lithuania.
Who is sponsoring the NCT05735704 clinical trial?
NCT05735704 is sponsored by JaxBio Ltd. The principal investigator is Yuval Prof. Ebenstein, PhD at Tel Aviv University. The trial plans to enroll 3,000 participants.