- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269592
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
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
Study Overview
Status
Conditions
- Myelodysplastic-Myeloproliferative Diseases
- Waldenstrom Macroglobulinemia
- Smoldering Multiple Myeloma
- Chronic Lymphocytic Leukemia (CLL)
- Hematological Malignancies
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- B-cell Malignancy, Low-grade
- Myelodysplastic Syndrome With Low-grade Lesions
- IgG Monoclonal Gammopathy of Uncertain Significance
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Irene Ghobrial, MD
- Phone Number: 617-632-4198
- Email: Irene_Ghobrial@dfci.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Dana-Farber Cancer Institute
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Contact:
- Irene Ghobrial, MD
- Phone Number: 617-632-4198
- Email: Irene_Ghobrial@dfci.harvard.edu
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Principal Investigator:
- Irene Ghobrial, MD
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Brighton, Massachusetts, United States, 02135
- Recruiting
- Dana Farber Cancer Institute at St. Elizabeth's
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Contact:
- Joseph Grider
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Principal Investigator:
- Olga Kozyreva, MD
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Methuen, Massachusetts, United States, 01844
- Recruiting
- Dana Farber Cancer Institute at Merrimack Valley
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Contact:
- Saida Hussain
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Principal Investigator:
- Pedro Sanz-Altamira, MD
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Milford, Massachusetts, United States, 01757
- Recruiting
- Dana Farber Cancer Institute at Milford Regional Medical Center
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Contact:
- Laura Melancon
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Principal Investigator:
- Michael Constantine, MD
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Weymouth, Massachusetts, United States, 02190
- Recruiting
- Dana Farber Cancer Institute at South Shore
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Principal Investigator:
- Irene Ghobrial, MD
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Contact:
- Rebeka Lovato
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Michigan
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Kalamazoo, Michigan, United States, 49007
- Recruiting
- West Michigan Cancer Center
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Contact:
- Kathleen Allen
- Phone Number: 269-373-7452
- Email: kallen@wmcc.org
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Principal Investigator:
- Mohammad Omaira, MD
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New Hampshire
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Londonderry, New Hampshire, United States, 03053
- Recruiting
- Dana Farber/New Hampshire Oncology-Hematology
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Principal Investigator:
- Jeanna Walsh, MD
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Contact:
- Shannon Peabody
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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);
- Myeloproliferative neoplasms (MPN);
- 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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identify molecular changes in cells of patients with precursor hematological malignancies
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Irene Ghobrial, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Blood Protein Disorders
- Precancerous Conditions
- Leukemia, B-Cell
- Hypergammaglobulinemia
- Chronic Disease
- Neoplasms
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Smoldering Multiple Myeloma
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Paraproteinemias
- Monoclonal Gammopathy of Undetermined Significance
Other Study ID Numbers
- 14-174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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