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