NCT02557243

Brief Summary

The aim of this study is to identify demographic \& disease characteristics in pediatric oncology patients diagnosed with soft tissue \& bone tumors involving the extremities \& treatment outcomes in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 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

First Submitted

Initial submission to the registry

September 21, 2015

Completed
2 days 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
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

3.8 years

First QC Date

September 21, 2015

Last Update Submit

January 7, 2020

Conditions

Keywords

Childhood CancerSoft Tissue TumorsBone TumorsExtremity TumorPediatric 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 bone \& soft tissue neoplasms involving the extremities, in the period from 2000 January till 2015 December, 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 bone \& soft tissue neoplasms involving the extremities.

You may not qualify if:

  • Patients whose age more than 19 years.
  • Patients diagnosed with bone \& soft tissue neoplasms not involving the extremities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (3)

  • Bakotic, B. W. (2001).

    BACKGROUND
  • Cormier JN, Pollock RE. Soft tissue sarcomas. CA Cancer J Clin. 2004 Mar-Apr;54(2):94-109. doi: 10.3322/canjclin.54.2.94.

    PMID: 15061599BACKGROUND
  • Sondak, V. (2000).

    BACKGROUND

MeSH Terms

Conditions

Soft Tissue NeoplasmsBone 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

September 21, 2015

First Posted

September 23, 2015

Study Start

January 1, 2016

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations