Evaluating Radiomorphometric Indices and Fractal Dimensio... | NCT04213482

Studies
Evaluating Radiomorphometric Indices and Fractal Dimension of the Pediatric Oncology Patients on Panoramic Images

NCT04213482

Sponsor

Nuh Naci Yazgan University

Status

Completed

Last Update Posted

Dec 30, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Oncology
Bone Loss

Interventions

Panoramic Radiography

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2018Actual

Primary Completion Date

Aug 20, 2018Actual

Completion Date

Dec 20, 2019Actual

First Submitted Date

Dec 23, 2019

First Submission Date that Met QC Criteria

Dec 25, 2019

First Posted Date

Dec 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 25, 2019

Last Update Posted Date

Dec 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hatice Cansu Kış, Assistant Professor, Nuh Naci Yazgan UniversityPrincipal Investigator

Lead Sponsor

Nuh Naci Yazgan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Cancer is the abnormal and uncontrolled proliferation of certain tissues in the body for a reason that cannot be determined yet. Childhood cancers occur between 0-17 years of age, and follow-up and treatment of these patients are performed in pediatric oncology services. Diagnosis in childhood cancers can be made by clinical examination as well as blood tests and examination of tissue samples. There are also some imaging methods used for diagnosis; ultrasonography, computed tomography, magnetic resonance imaging, positron emission tomography / computed tomography (PET / CT).

Treatment methods in childhood cancers are as follows; surgery, chemotherapy, radiotherapy and stem cell transplantation. Once diagnosed, oncologists and surgeons may choose one of these treatment options by mutual consultation or decide on a treatment method. Fractal analysis is a numerical as fractal dimension. Trabeculae are thin columns with numerous large spaces that give a honeycomb or spongy appearance of cancellous bone, which is also called trabecular bone or spongy bone. Previously, fractal analysis has been reported as a useful method to detect various diseases that affect the trabecular bone structure. Particularly in the field of dentistry, studies have shown that fractal analysis by the box-counting method can successfully evaluate trabecular changes in the mandible of patients with osteoporosis and periodontal diseases and in lactating women.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Panoramic Radiography	Radiation	Diagnostic Panoramic Dental Radiographs were taken.	healthy oncology patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

ongoing oncological treatment
patients who unwilling to participate to study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

23 Years

Standard Ages

ChildAdult

Study Population

Patients received chemotherapy and radiotherapy for a Pediatric oncologic disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nuh Naci Yazgan University		Kayseri	Kocasinan	38170	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

all types of data can be shared with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011862	Radiography, Panoramic

Ancestor Terms

ID	Term
D011861	Radiography, Dental
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided