NCI Community Oncology Research Program - Protocol Summary
NHLBI-MDS "The National Myelodysplastic Syndromes (MDS) Study"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Cancer Control Clinical Trial
CANCER TYPE: MDS
RESEARCH BASE: ECOG-ACRIN
NCT NUMBER: NCT02775383
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 02/13/2019 (21:35:23)
Collect clinical data and biological specimens in order to develop databases to support MDS studies. DCP-001 Eligible
THIS TRIAL IS DCP-001 ELIGIBLE
- Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.) MDS or MDS/MPN overlap disorders and undergoing diagnostic work-up with planned bone marrow assessments OR
- Diagnosed with de novo or therapy-related MDS within 6-months of enrollment per the World Health Organization (WHO) criteria1 and undergoing clinical evaluation and planned bone marrow assessments to confirm MDS or to evaluate disease status
- Bone marrow aspirate expected to be performed within 1 week of registration, and in all cases must be performed no later than 4 weeks after enrollment
- Age 18 or older
- No prior treatment for MDS at entry and through the time of the entry bone marrow aspirate
- No treatment with hematopoietic growth factors in prior 6 months
- B12 level, serum folate, ferritin, and Thyroid-Stimulating Hormone (TSH) tests performed in prior 6 months
- No diagnosis of a solid tumor or hematologic malignancy within two years prior to enrollment except for in situ cancer of the skin (basal or squamous cell), cervix, bladder, breast, or prostate
- No treatment with radiation therapy in the two years prior to registration
- No non-hormonal treatment for malignancy within the two years prior to registration
- No established hereditary bone marrow failure syndrome
- No known primary diagnosis of aplastic anemia, classical paroxysmal nocturnal hemoglobinuria, amegakaryocytic thrombocytopenic purpura, or large granular lymphocyte leukemia
- Not enrolled in the Connect® MDS/AML Disease Registry
- In participants with suspected MDS and prior to registration with subsequent bone marrow evaluation, alternative causes for the cytopenias should be considered (e.g., internal bleeding, autoimmune cytopenias, thyroid disorders, other causes of anemia etc.). In select individuals, the following tests could be performed to assist in the diagnostic work-up. These evaluations are not required by the protocol; however, abnormal results in advance of enrollment may reduce the number of non-MDS cases.
- Copper, serum level
- Iron studies (Iron, Total Iron-Binding Capacity (TIBC) Test, Percent Saturation)
- Direct Antiglobulin Test
- Antinuclear Antibody (ANA) Test