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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Fatma S E Ebeid, MD contact

01095569596

fatmaebeid@med.asu.edu.eg

Egypt2 sites, 2 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

    Recruiting

Other trials in Egypt

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 groups in NCT06935864
Study groupRoleWhat they receive
Prospective ArmChildren, 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.

  1. 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.

  1. First posted20 Apr 2025
  2. Study start16 Aug 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

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)
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

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.

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