NCT04831359

Brief Summary

Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

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

Study Start

First participant enrolled

February 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 29, 2021

Last Update Submit

April 2, 2021

Conditions

Pediatric Cancer Patients

Outcome Measures

Primary Outcomes (1)

  • Effect of chemotherapy on right ventricular function

    The correlation between echocardiographic parameters of the RV, measured with transthoracic echocardiography before and after chemotherapy

    Baseline to 45 days

Interventions

Doppler ultrasoundDEVICE

Tissue Doppler ultrasound on pediatric patients

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

\- Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute

You may qualify if:

  • Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute for receiving chemotherapy

You may not qualify if:

  • patients with left ventricular (EF) \<50% before chemotherapy
  • Previous heart disease
  • Renal failure
  • significant valvular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Related Publications (7)

  • Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol. 2009 Jun 10;27(17):2758-65. doi: 10.1200/JCO.2008.20.8983. Epub 2009 Apr 29.

    PMID: 19403886BACKGROUND

  • Dell'Italia LJ. The right ventricle: anatomy, physiology, and clinical importance. Curr Probl Cardiol. 1991 Oct;16(10):653-720. doi: 10.1016/0146-2806(91)90009-y. No abstract available.

    PMID: 1748012BACKGROUND

  • Carver JR, Shapiro CL, Ng A, Jacobs L, Schwartz C, Virgo KS, Hagerty KL, Somerfield MR, Vaughn DJ; ASCO Cancer Survivorship Expert Panel. American Society of Clinical Oncology clinical evidence review on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects. J Clin Oncol. 2007 Sep 1;25(25):3991-4008. doi: 10.1200/JCO.2007.10.9777. Epub 2007 Jun 18.

    PMID: 17577017BACKGROUND

  • Surkova E, Muraru D, Iliceto S, Badano LP. The use of multimodality cardiovascular imaging to assess right ventricular size and function. Int J Cardiol. 2016 Jul 1;214:54-69. doi: 10.1016/j.ijcard.2016.03.074. Epub 2016 Mar 25.

    PMID: 27057977BACKGROUND

  • Burgess MI, Bright-Thomas RJ, Ray SG. Echocardiographic evaluation of right ventricular function. Eur J Echocardiogr. 2002 Dec;3(4):252-62. No abstract available.

    PMID: 12413440BACKGROUND

  • Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

    PMID: 25559473BACKGROUND

  • Koestenberger M, Ravekes W, Everett AD, Stueger HP, Heinzl B, Gamillscheg A, Cvirn G, Boysen A, Fandl A, Nagel B. Right ventricular function in infants, children and adolescents: reference values of the tricuspid annular plane systolic excursion (TAPSE) in 640 healthy patients and calculation of z score values. J Am Soc Echocardiogr. 2009 Jun;22(6):715-9. doi: 10.1016/j.echo.2009.03.026. Epub 2009 May 7.

    PMID: 19423286BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Reham M Farghally

CONTACT

01094099458reham011214@med.au.edu..eg

Duaa M Raafat

CONTACT

01223112124Duaa-raafat@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 5, 2021

Study Start

February 20, 2021

Primary Completion

February 20, 2022

Study Completion

April 20, 2022

Last Updated

April 5, 2021

Record last verified: 2021-03

Locations

EG(1)