Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome
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|ClinicalTrials.gov Identifier: NCT02269592|
Recruitment Status : Recruiting
First Posted : October 21, 2014
Last Update Posted : November 2, 2018
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
|Condition or disease|
|Monoclonal Gammopathy of Undetermined Significance (MGUS) Chronic Lymphocytic Leukemia (CLL) Myelodysplastic-Myeloproliferative Diseases Hematological Malignancies B-cell Malignancy, Low-grade Myelodysplastic Syndrome With Low-grade Lesions IgG Monoclonal Gammopathy of Uncertain Significance Smoldering Multiple Myeloma Waldenstrom Macroglobulinemia|
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 :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Study of Precursor Hematological Malignancies to Assess the Relationship Between Molecular Events of Progression and Clinical Outcome|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||September 2021|
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
- Identify molecular changes in cells of patients with precursor hematological malignancies [ Time Frame: 10 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269592
|Contact: Irene Ghobrial, MD||617-632-4198||Irene_Ghobrial@dfci.harvard.edu|
|United States, Georgia|
|Northside Hospital, Inc.||Recruiting|
|Atlanta, Georgia, United States, 30342|
|Contact: Morgan Woody, MPH 404-236-8498 firstname.lastname@example.org|
|Principal Investigator: Sreeknath Reddy, MD|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Irene Ghobrial, MD 617-632-4198 Irene_Ghobrial@dfci.harvard.edu|
|Principal Investigator: Irene Ghobrial, MD|
|United States, Michigan|
|West Michigan Cancer Center||Recruiting|
|Kalamazoo, Michigan, United States, 49007|
|Contact: Kathleen Allen 269-373-7452 email@example.com|
|Principal Investigator: Mohammad Omaira, MD|
|Principal Investigator:||Irene Ghobrial, MD||Dana-Farber Cancer Institute|