- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663648
Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders
This study involves observing the level of cell cycle regulatory gene in patients with myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma will be used in laboratory studies.
Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the possible role in MPD and better understand the cause of MPD.
Study Overview
Status
Detailed Description
This study involves observing the level of cell cycle regulatory gene in patients with myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma will be used in laboratory studies.
Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the possible role in MPD and better understand the cause of MPD.
In this study, the cell cycle regulatory message RNA and protein from patients' and healthy volunteers' bone marrow and peripheral blood will be extracted and quantified by real time polymerase chain reaction and western blot. The different level of cell cycle regulatory gene between patients and volunteers and the relationship between the level and patients' clinical characteristics such as age, gender, type of disease will be analysed by SPSS.
Study Type
Contacts and Locations
Study Locations
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Shandong
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Jinan, Shandong, China, 250012
- Qilu Hospital, Shandong University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) or chronic myeloid leukemia (CML) as defined by the World Health Organization (WHO) diagnostic criteria
Exclusion Criteria:
- Have received treatment
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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quantified the level of CDK, CCP, PLK by real time PCR and westen blot
Time Frame: two years
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The cell cycle regulatory message RNA and protein from patients' and healthy volunteers' bone marrow and peripheral blood will be extracted and quantified by real time polymerase chain reaction and western blot.
The cell cycle regulatory genes contain CDK ,CDKI, Ser/Thr protein kinase, ATP/GTP binding protein-like and so on.
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two years
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age of MPN patients and volunteers
Time Frame: two years
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observe the age of MPN patients and volunteers, and analyze the correlation between the level and the age of patients.
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two years
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gender of MPN patients and volunteers
Time Frame: two years
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observe different level of cell cycle regulatory gene between male patients and femal patients.
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two years
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count of peripheral blood cells
Time Frame: two years
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observe the count of peripheral blood cells, including the white blood cell, red blood cell and platelet.
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two years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jun Peng, Qilu Hospital, Shandong University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Blood Platelet Disorders
- Leukemia
- Bone Marrow Neoplasms
- Hematologic Neoplasms
- Leukemia, Myeloid
- Disease
- Thrombocytosis
- Thrombocythemia, Essential
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myeloproliferative Disorders
- Polycythemia Vera
- Polycythemia
Other Study ID Numbers
- Cell cycle regulatory gene-MPD
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