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

Description

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

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS), Chronic Lymphocytic Leukemia (CLL), Myelodysplastic Syndromes, Hematological Malignancies, B-cell Malignancy, Low-grade, Myelodysplastic Syndrome With Low-grade Lesions, IgG Monoclonal Gammopathy of Uncertain Significance, Smoldering Multiple Myeloma, Waldenstrom Macroglobulinemia

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Intervention / Treatment

-

Contacts and Locations

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Brighton

Dana Farber Cancer Institute at St. Elizabeth's, Brighton, Massachusetts, United States, 02135

Methuen

Dana Farber Cancer Institute at Merrimack Valley, Methuen, Massachusetts, United States, 01844

Milford

Dana Farber Cancer Institute at Milford Regional Medical Center, Milford, Massachusetts, United States, 01757

Weymouth

Dana Farber Cancer Institute at South Shore, Weymouth, Massachusetts, United States, 02190

Kalamazoo

West Michigan Cancer Center, Kalamazoo, Michigan, United States, 49007

Londonderry

Dana Farber/New Hampshire Oncology-Hematology, Londonderry, New Hampshire, United States, 03053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dana-Farber Cancer Institute,

Irene Ghobrial, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

2030-09