Early detection and screening for blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fakultni Nemocnice Olomouc (Fnol)
  Olomouc, Czechia Recruiting
• National and Kapodistrian University of Athens (NKUA)
  Athens, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.