Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders

Chronic Myeloid Leukemia Clinical Trial

Official title:

Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02663648
• Other study ID #: Cell cycle regulatory gene-MPD
• Status: Withdrawn
• Phase: N/A
• First received: December 21, 2015
• Last updated: April 18, 2016
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: January 2016
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Essential Thrombocythemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Myelofibrosis
• Myeloproliferative Disorders
• Polycythemia
• Polycythemia Vera
• Thrombocythemia, Essential
• Thrombocytosis

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

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