Soft Tissue NeoplasmsNCT02557243
Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study
An observational study of Soft Tissue Neoplasms and Bone Neoplasms, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Soft Tissue Neoplasms, Bone Neoplasms
- How many people
- 163 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients whose age less than 19 years.
- Patients diagnosed with bone \& soft tissue neoplasms involving the extremities.
Who cannot join
- Patients whose age more than 19 years.
- Patients diagnosed with bone \& soft tissue neoplasms not involving the extremities.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background:
Sarcomas are a heterogeneous group of rare tumors that arise predominantly from the embryonic mesoderm. The various sarcomas include bone sarcomas (osteosarcomas and chondrosarcomas), Ewing's sarcomas, peripheral primitive neuroectodermal tumors, and soft tissue sarcomas.
Soft tissue sarcomas account for approximately 1% of adult malignancies and 7% to 15% of pediatric malignancies. Rhabdomyosarcoma is the most common soft tissue sarcoma of childhood.
There is some confusion within segments of the medical community as to the precise meaning of "soft tissue." The soft tissue of the human body includes all extraskeletal tissue that is neither epithelial, hematopoietic (marrow derived blood elements), nor parenchymal (constituent of a visceral organ). The nervous system is divided such that neither the glial nor the central neuronal elements are considered to be soft tissue, though by convention the peripheral nervous system is. In sum, the soft tissues consist of adipose tissue, fibrous tissue, musculature, vascular structures, and peripheral nerves.
About 50% to 60% of sarcomas occur in the extremities, and although they are rare, they are responsible for more deaths than testicular cancer, Hodgkin's disease, and thyroid cancer combined.
Patients \& Methods:
From January 2000 till December 2015, retrieval \& analysis of the medical records of pediatric patients with soft tissue \& bone tumors involving the extremities will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.
- Conditions
- Soft Tissue Neoplasms, Bone Neoplasms
- Keywords
- Childhood Cancer, Soft Tissue Tumors, Bone Tumors, Extremity Tumor, Pediatric Oncology
- Medical subject headings
- Soft Tissue Neoplasms, Bone Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from the date of initiation of treatment until death from any cause
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue 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
- 163 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
- NCT02557243
- Sponsor's protocol ID
- Ped Malig Extremities
- Other IDs
- IRB00008718
- Status last verified
- Jan 2020
- First submitted
- 21 Sep 2015
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakotic, B. W. (2001).
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.
PubMed 15061599Sondak, V. (2000).
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study
- ClinicalTrials.gov ID
- NCT02557243
- Acronym / sponsor ID
- Ped Malig Extremities
- Conditions
- Soft Tissue Neoplasms, Bone Neoplasms
- Keywords
- Childhood Cancer, Soft Tissue Tumors, Bone Tumors, Extremity Tumor, Pediatric Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Sep 2015 (estimated)
- 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.
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.
Detailed description
Background:
Sarcomas are a heterogeneous group of rare tumors that arise predominantly from the embryonic mesoderm. The various sarcomas include bone sarcomas (osteosarcomas and chondrosarcomas), Ewing's sarcomas, peripheral primitive neuroectodermal tumors, and soft tissue sarcomas.
Soft tissue sarcomas account for approximately 1% of adult malignancies and 7% to 15% of pediatric malignancies. Rhabdomyosarcoma is the most common soft tissue sarcoma of childhood.
There is some confusion within segments of the medical community as to the precise meaning of "soft tissue." The soft tissue of the human body includes all extraskeletal tissue that is neither epithelial, hematopoietic (marrow derived blood elements), nor parenchymal (constituent of a visceral organ). The nervous system is divided such that neither the glial nor the central neuronal elements are considered to be soft tissue, though by convention the peripheral nervous system is. In sum, the soft tissues consist of adipose tissue, fibrous tissue, musculature, vascular structures, and peripheral nerves.
About 50% to 60% of sarcomas occur in the extremities, and although they are rare, they are responsible for more deaths than testicular cancer, Hodgkin's disease, and thyroid cancer combined.
Patients \& Methods:
From January 2000 till December 2015, retrieval \& analysis of the medical records of pediatric patients with soft tissue \& bone tumors involving the extremities will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Patients whose age less than 19 years.
- Patients diagnosed with bone \& soft tissue neoplasms involving the extremities.
Key exclusion criteria (2 listed)
- Patients whose age more than 19 years.
- Patients diagnosed with bone \& soft tissue neoplasms not involving the extremities.
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: 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
Time from the date of initiation of treatment until death from any cause
Event Free Survival (EFS)
Time frame: 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
Time from the date of initiation of treatment until disease progression, or death for any reason.
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 10 Jan 2020.
- BackgroundBakotic, B. W. (2001).
- Background: PubMed 15061599Cormier JN, Pollock RE. Soft tissue sarcomas. CA Cancer J Clin. 2004 Mar-Apr;54(2):94-109. doi: 10.3322/canjclin.54.2.94.
- BackgroundSondak, V. (2000).
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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 Soft Tissue Neoplasms and 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 10 Jan 2020. 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: 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). 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 NCT02557243, which also lists 3 linked publications.
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 10 Jan 2020.