Assessing molecular changes in blood cancers
Study of Precursor Hematological Malignancies to Assess the Relationship Between Molecular Events of Progression and Clinical Outcome
This study is trying to see how changes in blood samples from people with early blood cancers can help us understand their condition better and find new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 7 sites (Boston, Massachusetts and 6 other locations) |
| Trial ID | NCT02269592 on ClinicalTrials.gov |
What this trial studies
This research focuses on analyzing molecular alterations in patients with precursor hematological cancers, such as MGUS, smoldering myeloma, and early MDS. By utilizing previously collected tissue samples and obtaining minimal additional samples, the study aims to link these molecular changes with clinical outcomes. The goal is to enhance understanding of how these alterations influence the progression of blood cancers and to potentially identify new therapeutic targets. Participants will not undergo any additional clinical procedures beyond standard care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with known or suspected precursor hematological cancers.
Not a fit: Patients with symptomatic hematological malignancies or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for patients with precursor blood cancers.
How similar studies have performed: Other studies have shown promise in identifying molecular alterations in blood cancers, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Known or Suspected Precursor Hematological Cancer * Including the following subgroups of diseases: * Early MDS, including pathologically-confirmed MDS (IPSS Low/Int-1; IPSS-R Very Low/Low) and idiopathic cytopenias of undetermined significance (ICUS); * Asymptomatic Multiple Myeloma and Waldenstrom Macroglobulinemia such as monoclonal gammopathy of undermined significance (MGUS) or Smoldering Multiple Myeloma (SMM or SWM); * Monoclonal B cell lymphocytosis (MBL); * Early stage asymptomatic low-grade lymphomas; or * Other precursor conditions or clonal genetic abnormalities of the blood/bone marrow that do not meet criteria for symptomatic hematological malignancy, or patients exposed to prior chemotherapies (e. g., alkylating agents, platinum derivatives, taxanes, topo-2 inhibitors, anti-metabolites, systemic radioisotopes). * Patients must be at least 18 years of age to participate in this research. * Inclusion of Women and Minorities -- In accordance with NIH guidelines, women and members of minority groups and their subpopulations will be included in this protocol. Exclusion Criteria: * Patients with Known or Suspected Precursor Hematological Cancer are NOT EXCLUDED * Evidence of symptomatic or active hematological malignancy. Patients enrolled on clinical trials for precursor diseases are NOT excluded from this study.
Where this trial is running
Boston, Massachusetts and 6 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute at St. Elizabeth's — Brighton, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute at Merrimack Valley — Methuen, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute at Milford Regional Medical Center — Milford, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute at South Shore — Weymouth, Massachusetts, United States (Recruiting)
- West Michigan Cancer Center — Kalamazoo, Michigan, United States (Recruiting)
- Dana Farber/New Hampshire Oncology-Hematology — Londonderry, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Irene Ghobrial, MD — Dana-Farber Cancer Institute
- Study coordinator: Irene Ghobrial, MD
- Email: precursor@partners.org
- Phone: 617-632-4198
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.