Clinical trial NCT02663648: Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders
Official title: Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myeloproliferative Disorders
Polycythemia Vera
Essential Thrombocythemia
Myelofibrosis
Chronic Myeloid Leukemia
Keywords: myeloproliferative disorders
cell cycle regulatory protein
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: quantified the level of CDK, CCP, PLK by real time PCR and westen blot
timeFrame: two years
measure: age of MPN patients and volunteers
timeFrame: two years
measure: gender of MPN patients and volunteers
timeFrame: two years
measure: count of peripheral blood cells
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Jun Peng
role: PRINCIPAL_INVESTIGATOR
References: