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

April 12, 2025 updated by: Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
      • Cairo, Egypt, 11566
        • Recruiting
        • Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
        • Contact:
          • Fatma Ebeid
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Immunohistochemical staining of 4 um sections prepared from paraffin blocks using KLF factor (4 and 7) by automated immunostaining using the streptavidin-biotin technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prognostic value
Time Frame: 1 year
Assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors,
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Fatma S E Ebeid, Faculty of Medicine Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

April 12, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD173/2024 (Other Identifier: Faculty of Medicine Ain Shams University Research Ethical Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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