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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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

Key Dates

Start date

Aug 31, 2014

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Sep 30, 2030

Study Design

Enrollment

10,000 participants (estimated)

Arms

• Arm: 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

• Irene Ghobrial, MD
  617-632-4198
  [email protected]

Locations (7)

Find similar trials in Boston, MA

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