Correlative Biomarker Study in Patients With Myeloproliferative Disorders

Correlative Biomarker Study for MPD-RC Treatment Studies in the Philadelphia Chromosome Negative MPD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00665067

Enrollment

592

Registered

2008-04-23

Start date

2007-04-30

Completion date

2018-07-20

Last updated

2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Thrombocythemia, Idiopathic Myelofibrosis, Myelofibrosis, Myeloproliferative Disease, Polycythemia Vera

Keywords

Myeloproliferative Disease, Myelofibrosis, Idiopathic Myelofibrosis, Essential Thrombocythemia, Polycythemia Vera, Biomarkers, Philadelphia Chromosome Negative, Clonal Hematopoietic malignancies

Brief summary

Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings will provide normal material like DNA for comparison with the abnormal material derived from the blood and/or bone marrow. The results of these studies will be correlated with subjects' disease symptoms and response to their experimental treatment. The MPD-RC researchers are interested in studying molecules from the blood and bone marrow, the exact molecules changing over time with the investigators choosing only the most promising for investigation. The investigators are attempting to better understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases. These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments. It is believed that further basic knowledge about these cancer cells as well as the effects of treatment will lead to the improvement of current therapies and the development of entirely new treatments for these diseases. The MPD-RC is hoping to determine if a number of laboratory tests (biomarkers) will allow for the prediction of response in future patients to the treatment they would receive.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients are to be registered to this study if they meet the eligibility criteria for one of the MPD-RC treatment protocols linked to this study. * Patients diagnosed with the following Myeloproliferative disorders including: polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) who are participating in treatment protocols of the MPD-RC are eligible. * Patients must have signed an informed consent to participate in a Myeloproliferative Disorders Research Consortium (MPD-RC) treatment study to which this protocol is a companion study. The subject must also have signed a consent to participate in this mandatory companion study.

Exclusion criteria

See inclusion criteria.

Design outcomes

Primary

Measure	Time frame
To collect and store tissue samples from patients with myeloproliferative disorders (PV,IM,and ET). Tissue samples will be used to perform a variety of biomarker studies to monitor the effects of a particular therapeutic intervention.	4 years

Countries

Canada, Italy, United Kingdom, United States

Outcome results