Study of Precursor Hematological Malignancies to Assess the Relationship between Molecular Events of Progression and Clinical Outcome (PCROWD)

Overview

The PCROWD, a tissue bank and clinical information repository, is an indispensable component of the research pipeline. Its main objective is to collect, process, and store tissue samples from patients with precursor blood conditions. Patients with such conditions have traditionally been told to "Watch and Wait" and have not had any treatment. The ability to follow these patients serially, i.e., at the same time they are followed clinically, will provide scientists with a rich source of samples and data.

The PCROWD is part of the Center for Prevention of Progression of Blood Cancers (CPOP), a research initiative at Dana-Farber Cancer Institute focused on understanding the progression and clonal evolution of blood cancers, with an ultimate aim to develop targeted therapeutic agents that can eliminate the early clones of disease. Some of the blood cancer precursor conditions being studied as part of this protocol are monoclonal gammopathy of undetermined significance (MGUS), Smoldering Multiple Myeloma (SMM) or Smoldering Waldenström Macroglobulinemia, Early Myelodysplastic Syndrome (MDS), Monoclonal B-Cell Lymphocytosis, and Myeloproliferative Neoplasms (MPN).

Research scientists at Dana-Farber identified a great need to create a large database of clinical and epidemiological information from patients with precursor conditions. In response to this need, Dana-Farber established the CPOP in 2014. This first of its kind clinic focuses solely on the identification of precursor conditions in patients, and the gathering of clinical and epidemiological information that will continually fuel research aimed at identifying novel therapeutic options to prevent or delay eventual disease progression.

SparkCures ID 759
Trial Phase Observational Trial
Enrollment 1000 Patients
Tags
Trial Sponsors
  • Dana-Farber Cancer Institute
Trial Collaborators
  • Leukemia and Lymphoma Society
NCT Identifier

NCT02269592

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

Patients with known or suspected precursor hematological conditions who have not had treatment which include the following subgroups of diseases are eligible to participate:

  • Early cases of Multiple Myeloma and Waldenström Macroglobulinemia (WM) such as monoclonal gammopathy of undetermined significance (MGUS), Smoldering Multiple Myeloma (SMM) or Smoldering Waldenström Macroglobulinemia
  • Early Myelodysplastic Syndrome (MDS)
  • Monoclonal B-Cell Lymphocytosis
  • Myeloproliferative Neoplasms (MPN), including patients treated with Hydroxyurea

The following criteria is provided for health care professionals.

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);
    • Myeloproliferative neoplasms (MPN);
    • 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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Northside Hospital

Atlanta, GA

West Michigan Cancer Center

Kalamazoo, MI

Georgia
Northside Hospital

Atlanta, GA

Massachusetts
Michigan
West Michigan Cancer Center

Kalamazoo, MI

Resources

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