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Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome
NCT02269592 · Dana-Farber Cancer Institute
In plain English
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Official title
Study of Precursor Hematological Malignancies to Assess the Relationship Between Molecular Events of Progression and Clinical Outcome
About this study
The purpose of this research study is to perform these molecular analyses on tissues (obtained from biopsies), blood, or other body fluids such as saliva. Importantly, this study will use tissue specimens that have already been collected as part of a participant's clinical care. The participant's tissue sample may be used to create a living tissue sample (called a "cell line") that can be grown in the laboratory. This allows researchers to have an unlimited supply of cells in the future without asking for more samples.
In this study, analyses will be performed on material only after all necessary clinical tests have been performed. In general, no additional procedures will be required. However, the investigators are asking the participant's permission to obtain one additional sample of blood (a few teaspoons), a gentle swab from the inside of their mouth or a sample of skin to obtain some cells. These are sources of normal, non-cancer cells which are needed for some types of analyses.
To fully understand the effects that molecular alterations have on blood cancers, they must be analyzed in the context of clinical behavior. Therefore, this study also asks the participant's permission to link the molecular alterations in their cancer or leukemia with clinical information that has been generated during the course of their clinical care. No additional clinical tests will be required. The investigator will ask to see the participant for follow up at regular interval to follow their risk of progression.
Some of participant's specimens as well as some of the material generated during the analysis of their tissues or blood may be useful for future study. The Investigator's are asking for the participant's permission to store these specimens and materials in a secure storage facility for possible later use.
Finally, rapid progress in understanding and treating cancer will occur when some of the molecular information derived from tissue and blood can be shared with other researchers. In particular, the National Institutes of Health (NIH) and other organizations have developed special data (information) repositories that analyze data and collect the results of certain types of genetic studies. These central banks will store genetic information and samples and give them to other researchers to do more studies. Therefore, the Investigators are also asking your permission to share your results with these special banks. The participant's information will be sent with only a code number attached. The participant's name or other directly identifiable information will not be given to central banks. There are many safeguards in place to protect the participant's information and samples while stored in repositories and used for research. The investigators do not think that there will be further risks to the participant's privacy and confidentiality by sharing this information with these banks. However, the investigator's cannot predict how genetic information will be used in the future.
Eligibility criteria
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 target: 10000 participants
Age groups: adult, older_adult
Timeline
Starts: 2014-08
Estimated completion: 2030-09
Last updated: 2026-05-07
Primary outcomes
- • Identify molecular changes in cells of patients with precursor hematological malignancies (10 years)
Sponsor
Dana-Farber Cancer Institute · other
With: The Leukemia and Lymphoma Society
Contacts & investigators
ContactIrene Ghobrial, MD · contact · precursor@partners.org · 617-632-4198
InvestigatorIrene Ghobrial, MD · principal_investigator, Dana-Farber Cancer Institute
All locations (7)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer Institute at St. Elizabeth'sRecruiting
Brighton, Massachusetts, United States
Dana Farber Cancer Institute at Merrimack ValleyRecruiting
Methuen, Massachusetts, United States
Dana Farber Cancer Institute at Milford Regional Medical CenterRecruiting
Milford, Massachusetts, United States
Dana Farber Cancer Institute at South ShoreRecruiting
Weymouth, Massachusetts, United States
West Michigan Cancer CenterRecruiting
Kalamazoo, Michigan, United States
Dana Farber/New Hampshire Oncology-HematologyRecruiting
Londonderry, New Hampshire, United States