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NCT02269592Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 7 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
9 Oct 2014
Start date
1 Aug 2014
Primary completion date
31 Dec 2027
Lead sponsor
Dana-Farber Cancer Institute
NCT number
NCT02269592

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 1 Aug 2014 to the primary completion date, 31 Dec 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Dana Farber Cancer Institute at St. Elizabeth's
Coordinator of this site? Confirm its status
BrightonUnited StatesRecruiting
West Michigan Cancer Center
Coordinator of this site? Confirm its status
KalamazooUnited StatesRecruiting
Dana-Farber/New Hampshire Oncology-Hematology
Coordinator of this site? Confirm its status
LondonderryUnited StatesRecruiting
Dana Farber Cancer Institute at Merrimack Valley
Coordinator of this site? Confirm its status
MethuenUnited StatesRecruiting
Dana Farber Cancer Institute at Milford Regional Medical Center
Coordinator of this site? Confirm its status
MilfordUnited StatesRecruiting
Dana Farber Cancer Institute at South Shore
Coordinator of this site? Confirm its status
WeymouthUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.