Pediatric Cancer PatientsNCT04831359
Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy
An observational study of Pediatric Cancer Patients, run by Assiut University at 1 site in Egypt.
Trial summary
Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Pediatric Cancer Patients
- What is being tested?
- Doppler ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 20 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Child
Study population: - Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute
Who may be able to join
- Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute for receiving chemotherapy
Who cannot join
- patients with left ventricular (EF) <50% before chemotherapy
- Previous heart disease
- Renal failure
- significant valvular disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut
Reham Farghally, 01094099458, reham011214@med.au.edu
Duaa Raafat, 01223112124, Duaa-Raafat@hotmail.com
About this study
Official title: Tissue Doppler Assessment of Right Ventricular Function in Newly Diagnosed Pediatric Cancer Patients Underwent Chemotherapy in South Egypt Cancer Institute
Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute.
Read the detailed description
The incidence of cancer is always increasing and it is predicted that the incidence will increase to 45% by 2030(1). The introduction of new chemotherapeutic agents significantly improved survival, but also revealed large spectrum of cardiotoxicity manifestations (2). There are many factors that increase the risk of cardiotoxicity caused by different chemotherapeutic agents, such as type of chemotherapy, cumulative dose, concomitant or previous radiotherapy, and comorbidities (3). Chemotherapeutic regimens which contain anthracyclines, cyclophosphamide, fluorouracil, cisplatin, taxanes and trastuzumab cause early and late cardiotoxicity (4).
The majority of published studies are focused on left ventricle dysfunction in patients receiving cardiotoxic chemotherapy. However, the right ventricle has been ignored for a long time and a little attention has been directed to show the effect of chemotherapy on right ventricle function. Right ventricle dysfunction is associated with increased morbidity and mortality in many cardiovascular diseases (5). The structure of cardiomyocytes and blood supply between the left and right ventricles are similar. Given the smaller mass and fewer myofibrils of right ventricle, chemotherapy may theoretically cause a more significant impact on it (6).
The right ventricle has a complex geometric shape which includes smooth muscular inflow, outflow and a trabecular apical region so echocardiographic assessment of right ventricle is difficult (7).
M-mode echocardiography, two-dimensional echocardiography, conventional Doppler echocardiography, and myocardial Doppler tissue imaging are all used to evaluate right ventricular function and provide accurate prognostic information especially when used in combination
- Conditions
- Pediatric Cancer Patients
- Being tested
- Doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundDevice
Tissue Doppler ultrasound on pediatric patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of chemotherapy on right ventricular function
The correlation between echocardiographic parameters of the RV, measured with transthoracic echocardiography before and after chemotherapy
Measured: Baseline to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start20 Feb 2021
- Primary completion20 Feb 2022 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pediatric Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham M Farghally, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831359
- Sponsor's protocol ID
- Tissue Doppler assesment
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19403886Dell'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.
PubMed 1748012Carver 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.
PubMed 17577017Surkova 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.
PubMed 27057977Burgess MI, Bright-Thomas RJ, Ray SG. Echocardiographic evaluation of right ventricular function. Eur J Echocardiogr. 2002 Dec;3(4):252-62. No abstract available.
PubMed 12413440Lang 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.
PubMed 25559473Koestenberger 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.
PubMed 19423286
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Doppler Assessment of Right Ventricular Function in Newly Diagnosed Pediatric Cancer Patients Underwent Chemotherapy in South Egypt Cancer Institute
- ClinicalTrials.gov ID
- NCT04831359
- Acronym / sponsor ID
- Tissue Doppler assesment
- Conditions
- Pediatric Cancer Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute.
Detailed description
The incidence of cancer is always increasing and it is predicted that the incidence will increase to 45% by 2030(1). The introduction of new chemotherapeutic agents significantly improved survival, but also revealed large spectrum of cardiotoxicity manifestations (2). There are many factors that increase the risk of cardiotoxicity caused by different chemotherapeutic agents, such as type of chemotherapy, cumulative dose, concomitant or previous radiotherapy, and comorbidities (3). Chemotherapeutic regimens which contain anthracyclines, cyclophosphamide, fluorouracil, cisplatin, taxanes and trastuzumab cause early and late cardiotoxicity (4).
The majority of published studies are focused on left ventricle dysfunction in patients receiving cardiotoxic chemotherapy. However, the right ventricle has been ignored for a long time and a little attention has been directed to show the effect of chemotherapy on right ventricle function. Right ventricle dysfunction is associated with increased morbidity and mortality in many cardiovascular diseases (5). The structure of cardiomyocytes and blood supply between the left and right ventricles are similar. Given the smaller mass and fewer myofibrils of right ventricle, chemotherapy may theoretically cause a more significant impact on it (6).
The right ventricle has a complex geometric shape which includes smooth muscular inflow, outflow and a trabecular apical region so echocardiographic assessment of right ventricle is difficult (7).
M-mode echocardiography, two-dimensional echocardiography, conventional Doppler echocardiography, and myocardial Doppler tissue imaging are all used to evaluate right ventricular function and provide accurate prognostic information especially when used in combination
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- - Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute
Key inclusion criteria (1 listed)
- Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute for receiving chemotherapy
Key exclusion criteria (4 listed)
- patients with left ventricular (EF) <50% before chemotherapy
- Previous heart disease
- Renal failure
- significant valvular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasoundTissue Doppler ultrasound on pediatric patients | Device | – |
Primary outcome
Effect of chemotherapy on right ventricular function
Time frame: Baseline to 45 days
The correlation between echocardiographic parameters of the RV, measured with transthoracic echocardiography before and after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Background: PubMed 19403886Smith 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.
- Background: PubMed 1748012Dell'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.
- Background: PubMed 17577017Carver 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.
- Background: PubMed 27057977Surkova 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.
- Background: PubMed 12413440Burgess MI, Bright-Thomas RJ, Ray SG. Echocardiographic evaluation of right ventricular function. Eur J Echocardiogr. 2002 Dec;3(4):252-62. No abstract available.
- Background: PubMed 25559473Lang 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.
- Background: PubMed 19423286Koestenberger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer Patients, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham M Farghally (01094099458, reham011214@med.au.edu..eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of chemotherapy on right ventricular function (time frame: Baseline to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831359, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.