Early Detection and Screening of Hematological Malignancies - SANGUINE (SANGUINE)
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ClinicalTrials.gov Identifier: NCT05735704 |
Recruitment Status :
Recruiting
First Posted : February 21, 2023
Last Update Posted : March 5, 2024
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Tracking Information | |||||||||
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First Submitted Date | January 31, 2023 | ||||||||
First Posted Date | February 21, 2023 | ||||||||
Last Update Posted Date | March 5, 2024 | ||||||||
Actual Study Start Date | January 30, 2023 | ||||||||
Estimated Primary Completion Date | January 31, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Early Detection and Screening of Hematological Malignancies - SANGUINE | ||||||||
Official Title | Early Detection and Screening of Hematological Malignancies - SANGUINE | ||||||||
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), non-Hodgkin aggressive lymphoma NHL [diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), Marginal Zone Lymphoma (MZL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and subjects at risk and control subjects with no malignant disease. | ||||||||
Detailed Description | Subjects will be screened for eligibility and then, after signing an Informed Consent Form, the first peripheral blood sample will be obtained. Periodical blood samples will be obtained from the participants. Relapse patients will have their retrospective blood samples analyzed to identify early signs of disease. 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, HGL, FL, and MZL transformed to large cell lymphoma), FL, MZL, AML, MDS, and control subjects with no malignant disease. In the second stage, at least 250 patients with MM and 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 at the clinical sites. Periodic sampling will be defined according to disease type and progression rate. Blood and plasma samples will be stored in the clinical sites until relapse diagnosis. At this stage, blood samples will be analyzed retrospectively on the HemaChip. The screening, enrollment and blood collection can begin in the first stage of the trial, in order to allow a maximum follow-up period for at-risk subjects as part of the study and to meet the recruitment goals. The last stage consists of the screening of a larger group of subjects with a high risk of blood cancer. This stage will include three populations: up to 1000 follow-up patients from each blood cancer: AML, lymphoma, and MM, up to 600 elderly patients (>65 years old) at risk of developing MM, and up to 400 first-degree relatives of patients (and in particular siblings). In order to allow a maximum follow-up period for at-risk subjects as part of the study, and to meet the recruitment goals, the screening, and enrollment can begin in the first stage of the trial. The last stage consists of screening a larger group of subjects at risk of developing MM / lymphoproliferative disorder. This stage will include 400 elderly patients (>65 years old) and 500 first-degree relatives of patients (and in particular siblings). The screening, enrollment, and sample collection can begin in the first stage of the trial, in order to allow a maximum follow-up period for at-risk subjects as part of the study and to meet the recruitment goals. In all stages, the age and sex-matched subgroups will be considered and matched. During the follow-up period, demographic and baseline parameters including sex, age, race, height and weight, medical history, smoking status, details of initial diagnosis and treatment history, concomitant medications as well as adverse events (AEs) of special interest (see section 9.1), (serious) AEs related to study procedures, treatment for the disease, disease response and survival status will be collected (as applicable). |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples Without DNA Description: Blood and bone marrow samples are collected and stored for 15 years from the end of the study
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Sampling Method | Probability Sample | ||||||||
Study Population | Adult subjects with 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), FL, MZL, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), subjects at risk and control subjects with no malignant disease. | ||||||||
Condition | Hematologic Malignancy | ||||||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
3000 | ||||||||
Original Estimated Enrollment |
6000 | ||||||||
Estimated Study Completion Date | January 31, 2026 | ||||||||
Estimated Primary Completion Date | January 31, 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria: General criteria for all study populations:
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, aggressive NHL (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, that were treated for their primary disease (FL/MZL/MDS/MPN) prior to study enrollment, are eligible. For subjects at risk for developing the investigated hematological malignancies:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | Czechia, Greece, Israel, Lithuania | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT05735704 | ||||||||
Other Study ID Numbers | SANGUINE | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Current Responsible Party | JaxBio Ltd | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | JaxBio Ltd | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators |
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Investigators |
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PRS Account | JaxBio Ltd | ||||||||
Verification Date | March 2024 |