Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT02269592

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Myelodysplastic Syndromes

Hematological Malignancies

B-cell Malignancy, Low-grade

Myelodysplastic Syndrome With Low-grade Lesions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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)

Myelodysplastic Syndromes

Hematological Malignancies

B-cell Malignancy, Low-grade

Myelodysplastic Syndrome With Low-grade Lesions

Study ID

NCT02269592

Start date

Aug, 2014

Status verified date

May, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Specimen Collection

Patients' tumor tissue including bone marrow, blood, buccal swab or mouthwash, lymph node, urine or other specimens will be collected from patients who consent to the protocol

Primary outcome measure

  • Identify molecular changes in cells of patients with precursor hematological malignancies [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Irene Ghobrial, MD

617-632-4198precursor@partners.org

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Irene Ghobrial, MD

617-632-4198precursor@partners.org

Principal Investigator:

Irene Ghobrial, MD

Dana Farber Cancer Institute at St. Elizabeth's

Recruiting

Brighton, Massachusetts, United States, 02135

Principal Investigator:

Olga Kozyreva, MD

Dana Farber Cancer Institute at Merrimack Valley

Recruiting

Methuen, Massachusetts, United States, 01844

Principal Investigator:

Pedro Sanz-Altamira, MD

Dana Farber Cancer Institute at Milford Regional Medical Center

Recruiting

Milford, Massachusetts, United States, 01757

Principal Investigator:

Michael Constantine, MD

Dana Farber Cancer Institute at South Shore

Recruiting

Weymouth, Massachusetts, United States, 02190

Principal Investigator:

Irene Ghobrial, MD

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Kathleen Allen

269-373-7452kallen@wmcc.org

Principal Investigator:

Mohammad Omaira, MD

Dana Farber/New Hampshire Oncology-Hematology

Recruiting

Londonderry, New Hampshire, United States, 03053

Principal Investigator:

Jeanna Walsh, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-05-07.