RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2014-08
Study Completion:2030-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02269592

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with Known or Suspected Precursor Hematological Cancer
  2. * Including the following subgroups of diseases:
  3. * Early MDS, including pathologically-confirmed MDS (IPSS Low/Int-1; IPSS-R Very Low/Low) and idiopathic cytopenias of undetermined significance (ICUS);
  4. * Asymptomatic Multiple Myeloma and Waldenstrom Macroglobulinemia such as monoclonal gammopathy of undermined significance (MGUS) or Smoldering Multiple Myeloma (SMM or SWM);
  5. * Monoclonal B cell lymphocytosis (MBL);
  6. * Early stage asymptomatic low-grade lymphomas; or
  7. * 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).
  8. * Patients must be at least 18 years of age to participate in this research.
  9. * 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.
  1. * Patients with Known or Suspected Precursor Hematological Cancer are NOT EXCLUDED
  2. * Evidence of symptomatic or active hematological malignancy. Patients enrolled on clinical trials for precursor diseases are NOT excluded from this study.

Contacts and Locations

Study Contact

Irene Ghobrial, MD
CONTACT
617-632-4198
precursor@partners.org

Principal Investigator

Irene Ghobrial, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute at St. Elizabeth's
Brighton, Massachusetts, 02135
United States
Dana Farber Cancer Institute at Merrimack Valley
Methuen, Massachusetts, 01844
United States
Dana Farber Cancer Institute at Milford Regional Medical Center
Milford, Massachusetts, 01757
United States
Dana Farber Cancer Institute at South Shore
Weymouth, Massachusetts, 02190
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Dana Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, 03053
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-08
Study Completion Date2030-09

Study Record Updates

Study Start Date2014-08
Study Completion Date2030-09

Terms related to this study

Keywords Provided by Researchers

  • MGUS
  • Smoldering Myeloma
  • Chronic Lymphocytic leukemia
  • Acute Myeloid Leukemia
  • Waldenstrom Macroglobulinemia
  • Monoclonal Gammopathy of Undermined Significance
  • Monoclonal B cell lymphocytosis
  • Smoldering Multiple Myeloma
  • Myelodysplastic syndromes

Additional Relevant MeSH Terms

  • 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