Early detection and screening for blood cancers
Early Detection and Screening of Hematological Malignancies - SANGUINE
This study is testing if analyzing blood samples can help spot early signs of blood cancers like multiple myeloma and lymphoma in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | JaxBio Ltd Industry-sponsored |
| Locations | 4 sites (Olomouc and 3 other locations) |
| Trial ID | NCT05735704 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, non-interventional study aims to identify and characterize epigenetic signatures associated with various hematological malignancies, including multiple myeloma and different types of lymphoma. Participants will undergo blood sampling to monitor disease progression and identify early signs of malignancy. The study will involve a discovery phase with at least 30 patients from each targeted group, followed by a larger cohort of 250 patients with multiple myeloma and 100 patients from other malignancies. Blood samples will be analyzed retrospectively to enhance early detection strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diagnosed hematological malignancies or those at risk, such as first-degree relatives of affected individuals or elderly patients over 65.
Not a fit: Patients currently diagnosed with another type of cancer or those with acute promyelocytic leukemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of hematological malignancies, improving patient outcomes through timely intervention.
How similar studies have performed: Other studies have shown promise in early detection of hematological malignancies using similar epigenetic approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Olomouc and 3 other locations
- Fakultni Nemocnice Olomouc (Fnol) — Olomouc, Czechia (Recruiting)
- National and Kapodistrian University of Athens (NKUA) — Atene, Greece (Recruiting)
- Tel-Aviv Sourasky Medical Center (TASMC) — Tel Aviv, Israel (Recruiting)
- Vilnus University Hospital Santaros Klinikos (VULSK) — Vilnius, Lithuania (Recruiting)
Study contacts
- Study coordinator: Helena Grinberg-Rashi, PhD
- Email: lenagrin@gmail.com
- Phone: +31615636666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.