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RecruitingNCT06935864Updated Apr 20, 2025

Tissue Expression of Krüppel-Like Factors 4 and 7 in Bone Tumors

An observational study in Osteosarcoma in Children and Ewing Sarcoma of Bone or Soft Tissue, sponsored by Ain Shams University. Recruiting at 2 sites in Egypt. Open to participants aged 1 Month to 39 Years. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by Ain Shams University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
1 Month to 39 Years
Sex
All
01

Study 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 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
02

Conditions studied

  • Osteosarcoma in Children
  • Ewing Sarcoma of Bone or Soft Tissue

Keywords

  • Bone Tumor
  • Osteosarcoma
  • Ewing sarcoma
03

In context

Bone Neoplasms

258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.

This study's planned enrollment of 30 is below the median of 101 across 82 observational studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children, adolescents, and young adults diagnosed with localized and metastatic both skeletal and extra-skeletal osteosarcoma and Ewing's sarcoma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age: children, young adolescents younger than 15 years, and young adults (15 to 39 years) Gender: Males and female. confirmed patients with skeletal or extra-skeletal OS or ES. Both localized and disease stages.

Exclusion criteria

Exclusion Criteria:

Patients with second malignant bone sarcoma. Patients with benign bone tumors.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: KLF factor (4 and 7)

Interventions

  • Diagnostic testKLF 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.

06

What researchers measure

Primary outcomes

  1. The prognostic value

    Assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors,

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06935864
Responsible party
Sponsor
First posted
Apr 20, 2025
Start date
Aug 16, 2024
Primary completion
Dec 2025 (estimated)
Completion
Feb 2026 (estimated)
Last update
Apr 20, 2025

Study contacts

Fatma S E Ebeid, MD
Contact
fatmaebeid@med.asu.edu.eg
01095569596
Fatma S E Ebeid
principal investigator · Faculty of Medicine Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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