OncologyNCT04213482
Evaluating Radiomorphometric Indices and Fractal Dimension of the Pediatric Oncology Patients on Panoramic Images
An observational study of Oncology and Bone Loss, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 23 yearsHealthy volunteers can take part
- What is being tested?
- Panoramic Radiography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2018to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients received chemotherapy and radiotherapy for a Pediatric oncologic disease
Who may be able to join
- to have been treated for any oncological diseases in childhood
- oncological treatment completed at least one year ago
Who cannot join
- ongoing oncological treatment
- patients who unwilling to participate to study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan University
Kayseri, Kocasinan, 38170
About this study
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.
Read the 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.
- Being tested
- Panoramic Radiography
- Keywords
- pediatric oncology, fractal analysis, panoramic mandibular indices, radiotherapy, chemotherapy
- Medical subject headings
- Neoplasms, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panoramic RadiographyRadiation
Diagnostic Panoramic Dental Radiographs were taken.
| Study group | Role | What they receive |
|---|---|---|
| oncology patients | For this study, panoramic images were taken from pediatric patients who received radiotherapy and/or chemotherapy because of any oncologic disease. Receives: 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. Receives: Radiation: Panoramic Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants to undergo a single assessment; to be measured at least 1 year after completion of oncologic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start15 May 2018
- Primary completion20 Aug 2018
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Cansu Kış, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213482
- Sponsor's protocol ID
- 2018/209
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all types of data can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Radiomorphometric Indices and Fractal Dimension of the Pediatric Oncology Patients on Panoramic Images
- ClinicalTrials.gov ID
- NCT04213482
- Acronym / sponsor ID
- 2018/209
- Keywords
- pediatric oncology, fractal analysis, panoramic mandibular indices, radiotherapy, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oncology patients | – | Radiation: Panoramic RadiographyFor this study, panoramic images were taken from pediatric patients who received radiotherapy and/or chemotherapy because of any oncologic disease. |
| healthy | – | Radiation: Panoramic Radiographypanoramic images of patients(pediatric) who have no systemic disease were collected from the archive of dental radiology clinic of the university hospital. |
Who may qualify
- Ages
- 6 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients received chemotherapy and radiotherapy for a Pediatric oncologic disease
Key inclusion criteria (2 listed)
- to have been treated for any oncological diseases in childhood
- oncological treatment completed at least one year ago
Key exclusion criteria (2 listed)
- ongoing oncological treatment
- patients who unwilling to participate to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panoramic RadiographyDiagnostic Panoramic Dental Radiographs were taken. | Radiation | healthy, oncology patients |
Primary outcome
Bone Mineral Density (BMD)
Time frame: Participants to undergo a single assessment; to be measured at least 1 year after completion of oncologic therapy
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: Undecided. all types of data can be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Bone Loss, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: Participants to undergo a single assessment; to be measured at least 1 year after completion of oncologic therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.