Clinical trial · Observational
Early Detection and Screening of Hematological Malignancies - SANGUINE
NCT05735704CI-TRIAL-00087714SANGUINEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling for HemaChip screening/diagnostic testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Patients with Hematological Malignancies - Discovery stage
- description
- 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, FL, MZL, AML, MDS. 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. Patients with a diagnosis of acute promyelocytic leukemia (APL) will not be included. For patients, it is expected, after signing the informed consent, that the serial samplings will be performed during the disease follow-up according to the standard clinical practice and/or recommended schedule and disease assessment plan.
- interventionNames
- Diagnostic Test: Blood sampling for HemaChip screening/diagnostic testing
- label
- Patients with Hematological Malignancies - Second stage
- description
- In the second stage, at least 250 patients with MM, 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 on at the clinical sites. Periodic sampling will be defined according to disease type and progression rate. Blood and plasma samples will be stored at clinical sites until relapse diagnosis. At this stage, blood samples will be analyzed retrospectively on the HemaChip. The screening, enrollment, and sample collection can begin in the first stage of the trial, to allow a maximum follow-up period for at-risk subjects as part of the study and to meet the recruitment goals.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.