Skip to main content
Clinical Trials/NCT06935864
NCT06935864RecruitingNot Applicable

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

Ain Shams University2 sites in 1 country30 target enrollmentStarted: August 16, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
The prognostic value

Study Overview

Brief 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.

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):

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Month to 39 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

The prognostic value

Time Frame: 1 year

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials