Early Detection and Screening of Hematological Malignancies - SANGUINE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 4
- 主要终点
- Validation of Hemachip
研究概览
简要总结
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
详细描述
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, DLBCL, FL, MZL, AML, MDS, and control subjects with no malignant disease.
In the second stage, at least 250 patients with MM 250 patients with NHL, at least 100 patients with each of the remaining hematological malignancies mentioned above, and control subjects with no malignant disease 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, to allow a maximum follow-up period, as part of the study, and to meet the recruitment goals.
The last stage consists of the screening of 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, to allow a maximum period for at-risk subjects cohort to meet the recruitment goals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General criteria for all study populations:
- •Male and female subjects ≥18 years of age
- •Ability to understand and willingness to sign a written informed consent document.
- •For Patients with hematological malignancies:
- •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.
- •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:
- •First-degree relatives; AND /OR
- •Elderly subjects ≥ 65 years of age.
排除标准
- •Patients/subjects with current co-diagnosis of another type of cancer;
- •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;
- •Patients with a diagnosis of acute promyelocytic leukemia (APL)
- •Patients/subjects with active inflammatory autoimmune disease that requires treatment with immunosuppressive/ immunomodulation agents;
- •Patients/subjects with known human immunodeficiency virus (HIV) positive;
- •Patients/subjects with known active Hepatitis A/B/C or past hepatitis C;
- •Subjects that are likely to be noncompliant with the protocol, or felt to be unsuitable by the investigator for any other reason.
结局指标
主要结局
Validation of Hemachip
时间窗: 36 month
Validating the discovery platform (HemaChip) as a diagnostic tool for various blood cancers.
population screening for hematological malignancies
时间窗: 36 month
Towards population screening - evaluate the sensitivity and specificity for screening in populations at risk for developing the investigated cancers: (i) elderly (\>65 years old) at high risk to develop MM; (ii) first degree relatives of the conditions described above.
Early detection for hematological malignancies
时间窗: 36 month
Towards early detection - Patients, at risk of relapse tested periodically to evaluate early detection capability of the HemaChip.
Biomarker discovery
时间窗: 36 month
define a set of differential epigenetic biomarkers that uniquely identify the following conditions: MM, pre-MM conditions (SMM and MGUS), HL, aggressive NHL (DLBCL, HGL, FL and MZL transformed to large cell lymphoma), FL, MZL, de novo AML, secondary AML, MDS and healthy subjects.
次要结局
未报告次要终点