NCT03839095

Brief Summary

To assess survival outcome of pediatric patients with localized osteosarcoma of the extremities in Upper Egypt, identify factors of prognostic significance for survival, and to determine factors predictive of surgical methods employed in these patients, and developing a clinical model for risk prediction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

February 9, 2019

Last Update Submit

February 11, 2019

Conditions

Keywords

Nonmetastatic OsteosarcomaPediatric CancerLimb SalvagePrediction Model

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    Participants will be retrospectively followed forward in time from the date of initiation of treatment till death from any cause, an expected average of 5 years

    From date of treatment initiation until the date of death from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months

  • Metastasis-Free survival (MFS)

    Participants will be retrospectively followed forward in time from the date of initiation of treatment till the occurrence of systemic recurrence, an expected average of 5 years

    From date of treatment initiation until the date of first documented systemic recurrence or patients censored at last follow up, whichever came first, assessed up to 60 months

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

30 pediatric patients with a histologically-verified non-metastatic osteosarcoma of the extremities treated at South Egypt Cancer Institute with a unified chemotherapy protocol between January 2001 and December 2015.

You may qualify if:

  • Patients whose age less than 19 years.
  • Patients diagnosed with verified osteosarcoma involving the extremities.

You may not qualify if:

  • Patients whose age more than 19 years.
  • Non-extremities Osteosarcoma .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (1)

  • Morsy AM, Abdelgawad MI, Ahmed BM, Rezk KM, Aboelgheit AM, Ramadan IK, Kamel HEM, Fouad DM, Herdan RA, Shabaan SH, Eltyb HA. Pediatric Osteosarcoma of Extremities: A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt. J Pediatr Hematol Oncol. 2019 Aug;41(6):e371-e383. doi: 10.1097/MPH.0000000000001407.

    PMID: 30629005BACKGROUND

MeSH Terms

Conditions

Bone NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBone DiseasesMusculoskeletal Diseases

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

February 9, 2019

First Posted

February 15, 2019

Study Start

January 1, 2018

Primary Completion

July 20, 2018

Study Completion

August 25, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations