NCT05782985

Brief Summary

The aim of the study is to evaluate the expression pattern of heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and K (HNRNPK) genes in Myeloproliferative neoplasms as a possible indicator of disease progression and as a potential therapeutic target

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

March 13, 2023

Last Update Submit

July 23, 2023

Conditions

Keywords

heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1)heterogeneous nuclear ribonucleoprotein K (HNRNPK)Myeloproliferative Neoplasms (MPNs)

Outcome Measures

Primary Outcomes (1)

  • Expression of Heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and Heterogeneous nuclear ribonucleoprotein K (HNRNPK) genes in myeloproliferative neoplasms (MPNs)

    Expression levels of Heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and Heterogeneous nuclear ribonucleoprotein K (HNRNPK) genes for diagnosis of myeloproliferative neoplasms.

    two years

Secondary Outcomes (1)

  • Correlation between expression levels of HNRNPH1 and HNRNPK genes and molecular diagnostic tests for myeloproliferative neoplasms

    Two years

Study Arms (2)

Myeloproliferative neoplasms Cases

The myeloproliferative neoplasms Cases will be tested for expression of heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and K (HNRNPK) genes

Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR)

Controls

Healthy controls will be tested for expression of heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and K (HNRNPK) genes

Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR)

Interventions

Blood samples from the myeloproliferative neoplasms cases and the controls will be tested with Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) for expression of heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and K (HNRNPK) genes.

ControlsMyeloproliferative neoplasms Cases

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed myeloproliferative neoplasms patients

You may qualify if:

  • The study will be carried out on patients newly diagnosed with one of the myeloproliferative neoplasms based on WHO Criteria for diagnosis of MPNs whether males or females and of any age.

You may not qualify if:

  • Other malignancies.
  • Patients on chemotherapy or radiotherapy.
  • Autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Department of Clinical Pathology

Asyut, Egypt

RECRUITING

Related Publications (10)

  • Tefferi A, Thiele J, Vardiman JW. The 2008 World Health Organization classification system for myeloproliferative neoplasms: order out of chaos. Cancer. 2009 Sep 1;115(17):3842-7. doi: 10.1002/cncr.24440.

    PMID: 19472396BACKGROUND
  • Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.

    PMID: 27069254BACKGROUND
  • Gallardo M, Lee HJ, Zhang X, Bueso-Ramos C, Pageon LR, McArthur M, Multani A, Nazha A, Manshouri T, Parker-Thornburg J, Rapado I, Quintas-Cardama A, Kornblau SM, Martinez-Lopez J, Post SM. hnRNP K Is a Haploinsufficient Tumor Suppressor that Regulates Proliferation and Differentiation Programs in Hematologic Malignancies. Cancer Cell. 2015 Oct 12;28(4):486-499. doi: 10.1016/j.ccell.2015.09.001. Epub 2015 Sep 24.

    PMID: 26412324BACKGROUND
  • Dreyfuss G, Matunis MJ, Pinol-Roma S, Burd CG. hnRNP proteins and the biogenesis of mRNA. Annu Rev Biochem. 1993;62:289-321. doi: 10.1146/annurev.bi.62.070193.001445. No abstract available.

    PMID: 8352591BACKGROUND
  • Du Q, Wang L, Zhu H, Zhang S, Xu L, Zheng W, Liu X. The role of heterogeneous nuclear ribonucleoprotein K in the progression of chronic myeloid leukemia. Med Oncol. 2010 Sep;27(3):673-9. doi: 10.1007/s12032-009-9267-z. Epub 2009 Aug 4.

    PMID: 19653139BACKGROUND
  • Han SP, Tang YH, Smith R. Functional diversity of the hnRNPs: past, present and perspectives. Biochem J. 2010 Sep 15;430(3):379-92. doi: 10.1042/BJ20100396.

    PMID: 20795951BACKGROUND
  • Garneau D, Revil T, Fisette JF, Chabot B. Heterogeneous nuclear ribonucleoprotein F/H proteins modulate the alternative splicing of the apoptotic mediator Bcl-x. J Biol Chem. 2005 Jun 17;280(24):22641-50. doi: 10.1074/jbc.M501070200. Epub 2005 Apr 18.

    PMID: 15837790BACKGROUND
  • Decorsiere A, Cayrel A, Vagner S, Millevoi S. Essential role for the interaction between hnRNP H/F and a G quadruplex in maintaining p53 pre-mRNA 3'-end processing and function during DNA damage. Genes Dev. 2011 Feb 1;25(3):220-5. doi: 10.1101/gad.607011.

    PMID: 21289067BACKGROUND
  • Braun S, Enculescu M, Setty ST, Cortes-Lopez M, de Almeida BP, Sutandy FXR, Schulz L, Busch A, Seiler M, Ebersberger S, Barbosa-Morais NL, Legewie S, Konig J, Zarnack K. Decoding a cancer-relevant splicing decision in the RON proto-oncogene using high-throughput mutagenesis. Nat Commun. 2018 Aug 17;9(1):3315. doi: 10.1038/s41467-018-05748-7.

    PMID: 30120239BACKGROUND
  • Panelli D, Lorusso FP, Papa F, Panelli P, Stella A, Caputi M, Sardanelli AM, Papa S. The mechanism of alternative splicing of the X-linked NDUFB11 gene of the respiratory chain complex I, impact of rotenone treatment in neuroblastoma cells. Biochim Biophys Acta. 2013 Feb;1829(2):211-8. doi: 10.1016/j.bbagrm.2012.12.001. Epub 2012 Dec 12.

    PMID: 23246602BACKGROUND

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Alaa Elminshawy, MD, Mac

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Elminshawy, MD, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

March 20, 2023

Primary Completion

March 20, 2025

Study Completion

June 1, 2025

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations