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The National Myelodysplastic Syndromes (MDS) Study

Status
Active
Cancer Type
Myelodysplastic Syndromes (MDS)
Trial Phase
Eligibility
18 and over, Male and Female
Study Type
Natural history/Epidemiology
Tissue collection/Repository
NCT ID
NCT02775383
Protocol IDs
NHLBI-MDS (primary)
NCI-2016-00281
Study Sponsor
ECOG-ACRIN Cancer Research Group

Summary

This research trial collects tissue samples from and studies the history of patients with myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN). Collecting and storing patients' bone marrow, blood, eyebrow hairs, buccal swab, skin, or other tissues to be studied in the laboratory in the future may help doctors learn more about MDS and blood disorders that may lead to MDS. Collecting information about patients and the treatments they receive may allow doctors to better understand how MDS changes over time and this knowledge may lead to better ways to prevent, detect, and treat MDS in the future.

Objectives

PRIMARY OBJECTIVES:

I. To develop a high-quality clinical database containing clinical history, including environmental exposure history, presenting signs and symptoms, diagnostic testing results, co-existing diseases, therapies and response to therapies, disease progression, quality of life and survival.

II. To develop a high-quality biorepository linked to the clinical data that will facilitate diverse studies, including genetic, epigenetic, immunologic, proteomic, and cell-functional and cell-phenotypic studies through the development of: central communication with the biorepository to ensure timely and accurate collections and biospecimen data appended to the clinical database; defined standard operating procedures for the collection, processing, storage and distribution, with special emphasis on processing protocols fit-for-purpose to sample requirements for downstream testing; and quality management procedures to ensure minimal numbers of errors in the management of the biospecimens.

III. To facilitate broad use of these linked data and specimens to support studies focused on: improving diagnostic accuracy, risk-stratification and prognostication, and medical decision-making in MDS; understanding quality of life and its relationship to changing disease and treatment status; understanding the pathogenesis of MDS and diverse MDS subtypes, including genetic, epigenetic, immunologic mechanisms; optimizing treatment strategies for specific subtypes of MDS; identifying novel biomarkers for MDS outcomes; and identifying novel targets for therapeutic interventions in MDS.

SECONDARY OBJECTIVES:

I. Detecting improved prognostic factors in low risk MDS. (Potential Studies)

II. Detecting markers of improved response to hypomethylating therapy. (Potential Studies)

III. Quality of life (QOL) and anemia therapy. (Potential Studies)

IV. Genetic factors in patients with complex karyotype. (Potential Studies)

V. Prognostic significance of splicing factor 3b subunit 1 (SF3B1) in MDS patients with refractory anemia with ring sideroblasts (RARS). (Potential Studies)

OUTLINE:

Patients undergo blood, bone marrow, eyebrow hairs, buccal swab and optional skin biopsy. Patients' medical records, baseline laboratory tests, quality of life, and diagnostic information including pathology reports and treatment history are also reviewed.

After the baseline visit, patients are followed up every 6 months. Follow up visits include disease evaluation, physical examination and collection of peripheral blood sample. Bone marrow biopsy and aspiration is performed when clinically necessary. Patients also complete the MDS-specific Qualify of Life in Myelodysplasia Scale (QUALMS), Functional Assessment of Cancer Therapy-General (FACT-G) (version 4), the Patient Reported Outcome Measurement Information System (PROMIS) Short Form version 1.0-Fatigue 7a, and the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L).

Treatment Sites in Georgia

Atlanta Cancer Care - Conyers


1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Decatur


2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge


7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Georgia Cancer Specialists - CenterPointe


1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Macon-Coliseum


308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Georgia Cancer Specialists - Stemmer


2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com

Northside Hospital Cancer Institute - Forsyth


1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041
404-303-3355
www.northside.com

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