Osteosarcoma in ChildrenNCT06935864
Tissue Expression of Krüppel-Like Factors 4 and 7 in Bone Tumors
An observational study of Osteosarcoma in Children and Ewing Sarcoma of Bone or Soft Tissue, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The current study is to assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors, and its role in the disease progression. Read more about this study
- Who is it for?
- Ages 1 month to 39 years
- Conditions the study is for
- Osteosarcoma in Children, Ewing Sarcoma of Bone or Soft Tissue
- What is being tested?
- KLF factor (4 and 7)
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 Aug 2024to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, adolescents, and young adults diagnosed with localized and metastatic both skeletal and extra-skeletal osteosarcoma and Ewing's sarcoma
Who may be able to join
- Age: children, young adolescents younger than 15 years, and young adults (15 to 39 years) Gender: Males and female. Histologically confirmed patients with skeletal or extra-skeletal OS or ES. Both localized and metastatic disease stages.
Who cannot join
- Patients with second malignant bone sarcoma. Patients with benign bone tumors.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams University
Cairo, 11566
Fatma Ebeid, 01095569596, fatmaebeid@med.asu.edu.eg
- Recruiting
Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
Cairo, 11566
Fatma Ebeid, 01095569596, fatmaebeid@med.asu.edu.eg
Fatma Ebeid
About this study
Official title: The Prognostic Value of Tissue Expression of Krüppel-Like Factors 4 and 7 in Bone Tumors
The current study is to assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors, and its role in the disease progression.
Read the detailed description
Krüppel-like factors are a group of proteins that engage in different cell functions including proliferation, apoptosis, autophagy, invasion, and migration, and have been discovered to play an important role in bone disease development.
Study Setting: Pediatric Hematology, Oncology and Bone Marrow Transplantation Unit at Ain Shams University Children's Hospital.
- Type of Study: Prospective cohort.
- Study Period: 12 months.
- Study Population: Children, adolescents, and young adults diagnosed with localized and metastatic both skeletal and extra-skeletal osteosarcoma and Ewing's sarcoma
- Sampling Method: Convenience
- The medical history by direct interview of participants or from the patients files with a focus on:
- Symptoms such as pain, swelling, and fracture including duration, intensity, and timing of complaint.
- Specific events for bone tumors include prior benign/malignant lesions, family history, and previous radiotherapy for a prior cancer.
- Assessment of the adverse outcomes.
- Treatment protocol, timing of local control, type of local surgical control, need for adjuvant or definitive radiation therapy.
- Examination carried out upon initial patients' presentation (collected from files in the historical group):
- A full physical examination including weight and height, with calculation of body mass index (BMI) and surface area (SA).
- Local examination with specific attention to the size, consistency of the swelling, its location and mobility, the relation of swelling to the involved bone, and the presence of regional/ local lymph nodes.
- Radiologic investigations at initial diagnosis, after induction chemotherapy, after local control, as well as at the end of therapy and every 3 months during 1st 2 years after therapy (collected from files in the historical group):
- Conventional radiographs in two planes
- Magnetic resonance imaging (MRI) of the whole compartment with adjacent joints,
- Computed tomography (CT) should be used only in the case of diagnostic problems or doubt, to visualize more clearly calcification, periosteal bone formation, or cortical destruction
- Stage classification: positron emission tomography (PET)/CT using General Electric device number 5632.
- Laboratory assessment at presentation for cohort group (collected from files in the historical group)
- Complete blood count (CBC)
- Electrolytes including serum Calcium, phosphorus, magnesium, bicarbonate; creatinine, blood urea nitrogen, liver enzymes, and lactate dehydrogenase (LDH)
- Pathological methods:
- Histopathological examination of H\&E-stained sections prepared from paraffin blocks at 4-5 um thickness.
- Immunohistochemical staining of 4 um sections prepared from paraffin blocks using KLF factor (4 and 7); this will be done with automated immunostaining using the streptavidin-biotin technique.
- Interpretation of the stained slides will be done using a semiquantitative score and the results will be statistically analyzed.
- Sample Size: 30 patients
- Being tested
- KLF factor (4 and 7)
- Keywords
- Bone Tumor, Osteosarcoma, Ewing sarcoma
- Medical subject headings
- Bone Neoplasms, Osteosarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLF factor (4 and 7)Diagnostic test
Immunohistochemical staining of 4 um sections prepared from paraffin blocks using KLF factor (4 and 7) by automated immunostaining using the streptavidin-biotin technique.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Arm | Children, young adolescents younger than 15 years, and young adults (15 to 39 years) with histologically confirmed patients with skeletal or extra-skeletal OS or ES with localized or metastatic disease stages. Receives: Diagnostic Test: KLF factor (4 and 7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognostic value
Assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors,
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start16 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma in ChildrenStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma S E Ebeid, Principal investigator, Faculty of Medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935864
- Sponsor's protocol ID
- FMASU MD173/2024
- Other IDs
- FMASU MD173/2024
- Status last verified
- Apr 2025
- First submitted
- 5 Jan 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Tissue Expression of Krüppel-Like Factors 4 and 7 in Bone Tumors
- ClinicalTrials.gov ID
- NCT06935864
- Acronym / sponsor ID
- FMASU MD173/2024
- Keywords
- Bone Tumor, Osteosarcoma, Ewing sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Apr 2025 (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.
The current study is to assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors, and its role in the disease progression.
Detailed description
Krüppel-like factors are a group of proteins that engage in different cell functions including proliferation, apoptosis, autophagy, invasion, and migration, and have been discovered to play an important role in bone disease development.
Study Setting: Pediatric Hematology, Oncology and Bone Marrow Transplantation Unit at Ain Shams University Children's Hospital.
- Type of Study: Prospective cohort.
- Study Period: 12 months.
- Study Population: Children, adolescents, and young adults diagnosed with localized and metastatic both skeletal and extra-skeletal osteosarcoma and Ewing's sarcoma
- Sampling Method: Convenience
- The medical history by direct interview of participants or from the patients files with a focus on:
- Symptoms such as pain, swelling, and fracture including duration, intensity, and timing of complaint.
- Specific events for bone tumors include prior benign/malignant lesions, family history, and previous radiotherapy for a prior cancer.
- Assessment of the adverse outcomes.
- Treatment protocol, timing of local control, type of local surgical control, need for adjuvant or definitive radiation therapy.
- Examination carried out upon initial patients' presentation (collected from files in the historical group):
- A full physical examination including weight and height, with calculation of body mass index (BMI) and surface area (SA).
- Local examination with specific attention to the size, consistency of the swelling, its location and mobility, the relation of swelling to the involved bone, and the presence of regional/ local lymph nodes.
- Radiologic investigations at initial diagnosis, after induction chemotherapy, after local control, as well as at the end of therapy and every 3 months during 1st 2 years after therapy (collected from files in the historical group):
- Conventional radiographs in two planes
- Magnetic resonance imaging (MRI) of the whole compartment with adjacent joints,
- Computed tomography (CT) should be used only in the case of diagnostic problems or doubt, to visualize more clearly calcification, periosteal bone formation, or cortical destruction
- Stage classification: positron emission tomography (PET)/CT using General Electric device number 5632.
- Laboratory assessment at presentation for cohort group (collected from files in the historical group)
- Complete blood count (CBC)
- Electrolytes including serum Calcium, phosphorus, magnesium, bicarbonate; creatinine, blood urea nitrogen, liver enzymes, and lactate dehydrogenase (LDH)
- Pathological methods:
- Histopathological examination of H\&E-stained sections prepared from paraffin blocks at 4-5 um thickness.
- Immunohistochemical staining of 4 um sections prepared from paraffin blocks using KLF factor (4 and 7); this will be done with automated immunostaining using the streptavidin-biotin technique.
- Interpretation of the stained slides will be done using a semiquantitative score and the results will be statistically analyzed.
- Sample Size: 30 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Arm | – | Diagnostic Test: KLF factor (4 and 7)Children, young adolescents younger than 15 years, and young adults (15 to 39 years) with histologically confirmed patients with skeletal or extra-skeletal OS or ES with localized or metastatic disease stages. |
Who may qualify
- Ages
- 1 month to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, adolescents, and young adults diagnosed with localized and metastatic both skeletal and extra-skeletal osteosarcoma and Ewing's sarcoma
Key inclusion criteria (1 listed)
- Age: children, young adolescents younger than 15 years, and young adults (15 to 39 years) Gender: Males and female. Histologically confirmed patients with skeletal or extra-skeletal OS or ES. Both localized and metastatic disease stages.
Key exclusion criteria (1 listed)
- Patients with second malignant bone sarcoma. Patients with benign bone tumors.
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 |
|---|---|---|
| KLF factor (4 and 7)Immunohistochemical staining of 4 um sections prepared from paraffin blocks using KLF factor (4 and 7) by automated immunostaining using the streptavidin-biotin technique. | Diagnostic test | Prospective Arm |
Primary outcome
The prognostic value
Time frame: 1 year
Assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Fatma S E Ebeid principal investigator
Faculty of Medicine Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma in Children and Ewing Sarcoma of Bone or Soft Tissue, run by Ain Shams University at 2 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma S E Ebeid, MD (01095569596, fatmaebeid@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prognostic value (time frame: 1 year). 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 20 Apr 2025.