Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders

Withdrawn

• Conditions: Myelofibrosis; Polycythemia Vera; Chronic Myeloid Leukemia; Myeloproliferative Disorders; Essential Thrombocythemia

• Registration Number: NCT02663648
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study First Submitted: 2015-12-21
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20
• Study Start: 2016-06
• Primary Completion: 2018-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quantified the level of CDK, CCP, PLK by real time PCR and westen blot	two years	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.
age of MPN patients and volunteers	two years	observe the age of MPN patients and volunteers, and analyze the correlation between the level and the age of patients.
gender of MPN patients and volunteers	two years	observe different level of cell cycle regulatory gene between male patients and femal patients.
count of peripheral blood cells	two years	observe the count of peripheral blood cells, including the white blood cell, red blood cell and platelet.

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China