NCT02557750

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.

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
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 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

September 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

7.7 years

First QC Date

September 22, 2015

Last Update Submit

July 21, 2023

Conditions

Hepatoblastoma

Keywords

Childhood CancerPediatric Oncology

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    Time from the date of initiation of treatment until death from any cause

    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

  • Event Free Survival (EFS)

    Time from the date of initiation of treatment until disease progression, or death for any reason.

    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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Patients whose age less than 19 years.
  • Patients diagnosed with hepatoblastoma.

You may not qualify if:

  • Patients whose age more than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Related Publications (8)

  • Bu, M., D. Terrada, et al. (2006).

    BACKGROUND

  • Douglass EC, Reynolds M, Finegold M, Cantor AB, Glicksman A. Cisplatin, vincristine, and fluorouracil therapy for hepatoblastoma: a Pediatric Oncology Group study. J Clin Oncol. 1993 Jan;11(1):96-9. doi: 10.1200/JCO.1993.11.1.96.

    PMID: 8380296BACKGROUND

  • Exelby PR, Filler RM, Grosfeld JL. Liver tumors in children in the particular reference to hepatoblastoma and hepatocellular carcinoma: American Academy of Pediatrics Surgical Section Survey--1974. J Pediatr Surg. 1975 Jun;10(3):329-37. doi: 10.1016/0022-3468(75)90095-0.

    PMID: 49416BACKGROUND

  • Mann JR, Kasthuri N, Raafat F, Pincott JR, Parkes SE, Muir KR, Ingram LC, Cameron AH. Malignant hepatic tumours in children: incidence, clinical features and aetiology. Paediatr Perinat Epidemiol. 1990 Jul;4(3):276-89. doi: 10.1111/j.1365-3016.1990.tb00651.x.

    PMID: 2374747BACKGROUND

  • Ortega JA, Krailo MD, Haas JE, King DR, Ablin AR, Quinn JJ, Feusner J, Campbell JR, Lloyd DA, Cherlow J, et al. Effective treatment of unresectable or metastatic hepatoblastoma with cisplatin and continuous infusion doxorubicin chemotherapy: a report from the Childrens Cancer Study Group. J Clin Oncol. 1991 Dec;9(12):2167-76. doi: 10.1200/JCO.1991.9.12.2167.

    PMID: 1720452BACKGROUND

  • Pritchard J, Brown J, Shafford E, Perilongo G, Brock P, Dicks-Mireaux C, Keeling J, Phillips A, Vos A, Plaschkes J. Cisplatin, doxorubicin, and delayed surgery for childhood hepatoblastoma: a successful approach--results of the first prospective study of the International Society of Pediatric Oncology. J Clin Oncol. 2000 Nov 15;18(22):3819-28. doi: 10.1200/JCO.2000.18.22.3819.

    PMID: 11078495BACKGROUND

  • Quinn JJ, Altman AJ, Robinson HT, Cooke RW, Hight DW, Foster JH. Adriamycin and cisplatin for hepatoblastoma. Cancer. 1985 Oct 15;56(8):1926-9. doi: 10.1002/1097-0142(19851015)56:83.0.co;2-g.

    PMID: 2411381BACKGROUND

  • von Schweinitz D, Byrd DJ, Hecker H, Weinel P, Bode U, Burger D, Erttmann R, Harms D, Mildenberger H. Efficiency and toxicity of ifosfamide, cisplatin and doxorubicin in the treatment of childhood hepatoblastoma. Study Committee of the Cooperative Paediatric Liver Tumour Study HB89 of the German Society for Paediatric Oncology and Haematology. Eur J Cancer. 1997 Jul;33(8):1243-9. doi: 10.1016/s0959-8049(97)00095-6.

    PMID: 9301450BACKGROUND

MeSH Terms

Conditions

HepatoblastomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Pediatric Oncology Department

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 23, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

EG(1)