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Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome

RecruitingObservational study

Study of Precursor Hematological Malignancies to Assess the Relationship Between Molecular Events of Progression and Clinical Outcome

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

Blood cancers occur when the molecules that control normal cell growth are damaged. Many of these changes can be detected by directly examining parts of the cancer or cells in blood. Several alterations that occur repeatedly in certain types of blood cancers have already been identified, and these discoveries have led to the development of new drugs that target those alterations. More remain to be discovered.

Some of these abnormalities include alterations in genes. Genes are the part of cells that contain the instructions which tell the investigators bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are composed of DNA letters that spell out these instructions. Studies of the DNA molecules that make up the genes are called "molecular" analyses. Molecular analyses are ways of reading the DNA letters to identify errors in genes that may contribute to an increased risk of cancer or to the behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur in the genes that are passed from parent to child. This research study will examine both kinds of genes. The best way to find these genes is to study large numbers of people. The investigators expect that as many 1000 individuals will enroll in this study.

This research study is trying to help doctors and scientists understand why cancer occurs and to develop ways to better treat and prevent it. To participate in this study the participant must have cancer now, had it in the past, or are at risk of developing cancer. The participant will not undergo tests or procedures that are not required as part of their routine clinical care. The investigators will ask the participant to provide an additional sample from tissue that is obtained for their clinical care including blood, bone marrow, or tissue sample. The investigators will also ask for a gentle scrape of the inside of their cheek, mouthwash or a skin sample to obtain their germline DNA

Sponsor: Dana-Farber Cancer Institute · Participants: 10,000 · Started: 2014-08

Contact the study team

Irene Ghobrial, MD · Phone: 617-632-4198

Official record on ClinicalTrials.gov — NCT02269592

Locations in the U.S.

Massachusetts	Dana-Farber Cancer Institute, Boston Dana Farber Cancer Institute at St. Elizabeth's, Brighton Dana Farber Cancer Institute at Merrimack Valley, Methuen Dana Farber Cancer Institute at Milford Regional Medical Center, Milford Dana Farber Cancer Institute at South Shore, Weymouth
Michigan	West Michigan Cancer Center, Kalamazoo
New Hampshire	Dana Farber/New Hampshire Oncology-Hematology, Londonderry

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.