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Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

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ClinicalTrials.gov Identifier: NCT02557750
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Morsy, MD, Assiut University

Brief Summary:
The aim of this study is to retrospectively investigate the effect of combined modality treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance with the experience at the pediatric oncology department at South Egypt Cancer Institute.

Condition or disease
Hepatoblastoma

Detailed Description:

Background:

Hepatoblastoma (HB) is the most common malignant liver tumor in children, with an incidence of 0.7 to 1 per million children <15 years of age. Till 1970s, surgery was the primary modality of treatment of HB. Unfortunately, up to 60% of the patients present in an unresectable stage. Later, the chemo- responsiveness of the tumor was demonstrated which led to the incorporation of adjuvant chemotherapy with cisplatinum and doxorubicin in the treatment of HB. International Society of Pediatric Oncology (SIOP) pioneered the concept of neoadjuvant chemotherapy in the management of HB.

Patients & Methods:

In the period from 2002 January till 2016 January, retrieval & analysis of the medical records of pediatric patients with hepatoblastoma will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. After pathologic confirmation of the diagnosis, these data will be categorized according to patients' demographics, presenting features, laboratory studies, including tumor markers & histologic subtype, radiographic evaluation, disease staging, treatment course given, and subsequent treatment outcomes.


Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience
Study Start Date : January 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years ]
    Time from the date of initiation of treatment until death from any cause

  2. Event Free Survival (EFS) [ Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years ]
    Time from the date of initiation of treatment until disease progression, or death for any reason.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric cancer patients, those diagnosed with hepatoblastoma, in the period from 2002 January till 2016 January, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
Criteria

Inclusion Criteria:

  • Patients whose age less than or equal to 18 years.
  • Patients diagnosed with hepatoblastoma.

Exclusion Criteria:

  • Patients whose age more than 18 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557750


Locations
Egypt
Assiut University Recruiting
Assiut, Egypt, 71515
Contact: Ahmed M. Morsy, MD    +2 01003314522    ahmedmohammed7829@yahoo.com   
Principal Investigator: Ahmed M. Morsy, MD         
Principal Investigator: Khalid M. Rezk, MD         
Principal Investigator: Ameer M. Abuelgheet, MD         
Sponsors and Collaborators
Assiut University

Publications:
Bu, M., D. Terrada, et al. (2006).

Responsible Party: Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
ClinicalTrials.gov Identifier: NCT02557750     History of Changes
Other Study ID Numbers: Comb Mod Hepatoblastoma SECI
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Keywords provided by Ahmed Mohammed Morsy, MD, Assiut University:
Childhood Cancer
Pediatric Oncology

Additional relevant MeSH terms:
Hepatoblastoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms