NCT04213482

Brief Summary

This study evaluated pediatric oncology patients in terms of quality of bone and determine any relation between bone quality and radiotherapy/chemotherapy. The alternative hypothesis is that the bone quality of the oncology patients who received radiotherapy/chemotherapy is lower than the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

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

May 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

3 months

First QC Date

December 23, 2019

Last Update Submit

December 25, 2019

Conditions

Keywords

pediatric oncologyfractal analysispanoramic mandibular indicesradiotherapychemotherapy

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density (BMD)

    Fractal Dimension of the mandibular bone in patients with pediatric oncologic diseases will be measured on dental panoramic images to asses bone mineral density of mandibula. Image J software will be used to Fractal Analysis measurements.

    Participants to undergo a single assessment; to be measured at least 1 year after completion of oncologic therapy

Study Arms (2)

oncology patients

For this study, panoramic images were taken from pediatric patients who received radiotherapy and/or chemotherapy because of any oncologic disease.

Radiation: Panoramic Radiography

healthy

panoramic images of patients(pediatric) who have no systemic disease were collected from the archive of dental radiology clinic of the university hospital.

Radiation: Panoramic Radiography

Interventions

Diagnostic Panoramic Dental Radiographs were taken.

healthyoncology patients

Eligibility Criteria

Age6 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients received chemotherapy and radiotherapy for a Pediatric oncologic disease

You may qualify if:

  • to have been treated for any oncological diseases in childhood
  • oncological treatment completed at least one year ago

You may not qualify if:

  • ongoing oncological treatment
  • patients who unwilling to participate to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Kocasinan, 38170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsBone Diseases, Metabolic

Interventions

Radiography, Panoramic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography, DentalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnosis, OralDentistry

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 30, 2019

Study Start

May 15, 2018

Primary Completion

August 20, 2018

Study Completion

December 20, 2019

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations