Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-01 @ 8:51 PM
Study NCT ID:
NCT04831359
Status:
UNKNOWN
Last Update Posted:
2021-04-05
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018608', 'term': 'Ultrasonography, Doppler'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-02', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-04-02', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of chemotherapy on right ventricular function', 'timeFrame': 'Baseline to 45 days', 'description': 'The correlation between echocardiographic parameters of the RV, measured with transthoracic echocardiography before and after chemotherapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Cancer Patients']}, 'referencesModule': {'references': [{'pmid': '19403886', 'type': 'BACKGROUND', 'citation': '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': '1748012', 'type': 'BACKGROUND', 'citation': "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': '17577017', 'type': 'BACKGROUND', 'citation': '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': '27057977', 'type': 'BACKGROUND', 'citation': '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': '12413440', 'type': 'BACKGROUND', 'citation': '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': '25559473', 'type': 'BACKGROUND', 'citation': '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': '19423286', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute.', 'detailedDescription': '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).\n\nThe 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).\n\nThe 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).\n\nM-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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute for receiving chemotherapy\n\nExclusion Criteria:\n\n1. patients with left ventricular (EF) \\<50% before chemotherapy\n2. Previous heart disease\n3. Renal failure\n4. significant valvular disease'}, 'identificationModule': {'nctId': 'NCT04831359', 'briefTitle': 'Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Tissue Doppler Assessment of Right Ventricular Function in Newly Diagnosed Pediatric Cancer Patients Underwent Chemotherapy in South Egypt Cancer Institute', 'orgStudyIdInfo': {'id': 'Tissue Doppler assesment'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Doppler ultrasound', 'type': 'DEVICE', 'description': 'Tissue Doppler ultrasound on pediatric patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Reham Farghally', 'role': 'CONTACT', 'email': 'reham011214@med.au.edu', 'phone': '01094099458'}, {'name': 'Duaa Raafat', 'role': 'CONTACT', 'email': 'Duaa-Raafat@hotmail.com', 'phone': '01223112124'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Reham M Farghally', 'role': 'CONTACT', 'email': 'reham011214@med.au.edu..eg', 'phone': '01094099458'}, {'name': 'Duaa M Raafat', 'role': 'CONTACT', 'email': 'Duaa-raafat@hotmail.com', 'phone': '01223112124'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Reham M Farghally', 'investigatorAffiliation': 'Assiut University'}}}}