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The National Myelodysplastic Syndromes Natural History Study (The National MDS Study) is underway, the ECOG-ACRIN Cancer Research Group and its collaborators announced today. This new study, funded by the National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI), and performed in collaboration with the National Cancer Institute (NCI), will collect detailed information and biological samples from 2000 adults with myelodysplastic syndromes (MDS) and 500 more patients receiving care for a persistent low red blood cell count (anemia) that cannot be explained. Its purpose is to build a national resource to be used by scientists in future research.

A third group will be formed as a comparison cohort by selecting 1000 patients who will be screened in the study because of symptoms of MDS, but who will be found to not actually have one of the blood disorders. In total, the study will enroll up to 3500 patients, making it the largest-ever prospective study of MDS in the U.S.

It is hoped that this national resource will help researchers to identify the causes and genetic makeup of these serious and sometimes fatal diseases. Other research could lead to new and better ways to diagnosis and treat these conditions.

MDS occur when the blood-forming cells in the bone marrow are damaged and have problems making new blood cells. Considered a type of cancer, these abnormal blood cells fail to grow properly and die sooner than normal cells, leaving affected individuals with low blood counts and a shorter lifespan. Treatment options depend on the disease severity at diagnosis and are limited in their effectiveness.

About 30,000 people every year develop MDS, which occur mostly in adults over 60 years of age and more often in men than women. Common symptoms of MDS include fatigue, unusual bleeding, bruises, and tiny red marks under the skin, paleness, and shortness of breath.

Many people with MDS develop a serious or life-threatening anemia. About one-third of people with MDS develop acute myeloid leukemia, an aggressive blood cancer.

There are many questions about the causes of MDS and what patients can expect during the course of the disease. Unfortunately, MDS lacks a large collection of patient-related disease information and human tissue samples, such as diseased blood and bone marrow samples, which provide the opportunity for scientific research and breakthroughs. Such resources are already in place for other more common diseases, but not yet for MDS.

People 18 years of age or older who agree to participate in The National MDS Study will donate blood, bone marrow, and other body tissues (eyebrow hair, cells from the insides of the cheeks, and skin) to give researchers information to study how these blood disorders change over time. Patients will also answer quality of life questionnaires on how the disease affects their physical and emotional well-being over time.

This study requires the participation of a large network of physicians who support medical research and who examine people experiencing the symptoms of MDS. A number of organizations are collaborating on this effort. For patient recruitment, which is expected to take five to seven years, the NCI is contributing access to its two large cancer research networks, the NCI National Clinical Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP).

Physicians may enroll their patients in this study if they and their hospital, practice, or cancer center are a member of any cancer research group that belongs to either NCI network. These groups are the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG.

ECOG-ACRIN Cancer Research Group, which is leading the study, has added The National MDS Study to its portfolio of active clinical trials in leukemia, thus streamlining its implementation at clinical centers nationwide.

Patients' blood, bone marrow, and other body tissues will be processed and stored at a central laboratory and biorepository at the Moffitt Cancer Center and its M2Gen subsidiary in Tampa, Fla. Patient information and data from patient samples will be linked and stored centrally at a data coordinating center, under the supervision of The Emmes Corporation, which is coordinating the trial.

At the end of this study, the collected data and specimens will be transferred to the NHLBI and will be available to scientists throughout the country for their own research studies. In this way, The National MDS Study will enable scientists to answer questions about MDS that up to this point have been impractical to study at a single institution or even among small groups of researchers.

Source: ECOG-ACRIN Cancer Research Group

May 25, 2016 05:44 PMHealth & Medicine




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