Bone NeoplasmsNCT03839095
Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model
An observational study of Bone Neoplasms, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Bone Neoplasms
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 25 Aug 2018
- 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 Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients whose age less than 19 years.
- Patients diagnosed with verified osteosarcoma involving the extremities.
Who cannot join
- Patients whose age more than 19 years.
- Non-extremities Osteosarcoma .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Localized Osteosarcoma of Extremities: Developing a Clinical Prediction Model From a Country With Limited Resources
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.
Read the detailed description
Background Osteosarcoma is the most common of all primary malignant bone tumors. Accounting for about 2.6% of all pediatric neoplasms, it predominantly occurs in the extremities, with a peak incidence in the second decade of life.
In Upper Egypt, we have a higher proportion of the population in underdeveloped communities with limited access to medical care so the patients usually seek medical advice at advanced stage leading to a higher prevalence of metastatic disease at initial presentation, as well as a greater proportion of larger tumor size that more likely to be associated with potential adverse risk criteria prior to surgery.
A previous study from Upper Egypt showed that a metastatic disease at diagnosis was independently correlated to a dismal outcome. Since the effect of many other factors of prognostic significance, such as, gender, age, tumor location and response to chemotherapy may have been mitigated by the large effect of the metastatic disease on the prognosis; So, here, we will analyze the data of 30 patients with non-metastatic osteosarcoma of the extremities, to determine prognostic factors associated with survival, and also to develop a model for a better prediction of factors correlated to that a certain surgical approach was employed in these patients based on their baseline clinical data and the tumor response to chemotherapy.
Patients \& Methods We will carry out a retrospective analysis of data assembled from medical records of 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. These data will be categorized according to demographic data, clinical characteristics, tumor response to chemotherapy, and surgical methods employed in these patients. Prognostic factors will be determined using univariable and multivariable methods. A predictive model for surgical outcomes in these patients based on the baseline clinical factors, and their tumor response to chemotherapy will be developed.
- Conditions
- Bone Neoplasms
- Keywords
- Nonmetastatic Osteosarcoma, Pediatric Cancer, Limb Salvage, Prediction Model
- Medical subject headings
- Bone Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2018
- Primary completion20 Jul 2018
- Study completion25 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Morsy, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839095
- Sponsor's protocol ID
- IRB_Os_Pred_Mod
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
Publications
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.
PubMed 30629005
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Osteosarcoma of Extremities: Developing a Clinical Prediction Model From a Country With Limited Resources
- ClinicalTrials.gov ID
- NCT03839095
- Acronym / sponsor ID
- IRB_Os_Pred_Mod
- Conditions
- Bone Neoplasms
- Keywords
- Nonmetastatic Osteosarcoma, Pediatric Cancer, Limb Salvage, Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 25 Aug 2018 (actual)
- First posted
- 15 Feb 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.
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.
Detailed description
Background Osteosarcoma is the most common of all primary malignant bone tumors. Accounting for about 2.6% of all pediatric neoplasms, it predominantly occurs in the extremities, with a peak incidence in the second decade of life.
In Upper Egypt, we have a higher proportion of the population in underdeveloped communities with limited access to medical care so the patients usually seek medical advice at advanced stage leading to a higher prevalence of metastatic disease at initial presentation, as well as a greater proportion of larger tumor size that more likely to be associated with potential adverse risk criteria prior to surgery.
A previous study from Upper Egypt showed that a metastatic disease at diagnosis was independently correlated to a dismal outcome. Since the effect of many other factors of prognostic significance, such as, gender, age, tumor location and response to chemotherapy may have been mitigated by the large effect of the metastatic disease on the prognosis; So, here, we will analyze the data of 30 patients with non-metastatic osteosarcoma of the extremities, to determine prognostic factors associated with survival, and also to develop a model for a better prediction of factors correlated to that a certain surgical approach was employed in these patients based on their baseline clinical data and the tumor response to chemotherapy.
Patients \& Methods We will carry out a retrospective analysis of data assembled from medical records of 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. These data will be categorized according to demographic data, clinical characteristics, tumor response to chemotherapy, and surgical methods employed in these patients. Prognostic factors will be determined using univariable and multivariable methods. A predictive model for surgical outcomes in these patients based on the baseline clinical factors, and their tumor response to chemotherapy will be developed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Patients whose age less than 19 years.
- Patients diagnosed with verified osteosarcoma involving the extremities.
Key exclusion criteria (2 listed)
- Patients whose age more than 19 years.
- Non-extremities Osteosarcoma .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: 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
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
Metastasis-Free survival (MFS)
Time frame: 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
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
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 15 Feb 2019.
- Background: PubMed 30629005Morsy 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.
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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 Bone Neoplasms, run by Assiut University at 1 site in Egypt.
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 15 Feb 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 Egypt. 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?
Overall survival (OS) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839095, which also lists 1 linked publication.
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 15 Feb 2019; AzTrials last refreshed its copy on 29 Oct 2026.