Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders

NCT02663648 | Withdrawn DMC

• 1 other identifier: Cell cycle regulatory gene-MPD
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloproliferative Disorders; Polycythemia Vera; Essential Thrombocythemia; Myelofibrosis; Chronic Myeloid Leukemia

Keywords

myeloproliferative disorders; cell cycle regulatory protein

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• gender of MPN patients and volunteers

  observe different level of cell cycle regulatory gene between male patients and femal patients.

  two years

• count of peripheral blood cells

  observe the count of peripheral blood cells, including the white blood cell, red blood cell and platelet.

  two years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Have received treatment

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Polycythemia Vera; Thrombocythemia, Essential; Primary Myelofibrosis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Peng

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 26, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2020
• Last Updated: April 20, 2016

Record last verified: 2016-01

Locations

CN (1)