Exploring the Expression Level of Cadherin 6 Protein (CDH6) in Primary Malignant Bone Tumor Specimens and Its Clinical Application in Prognosis Assessment

NCT06850506 | Active Not Recruiting DMC

• 1 other identifier: PKUPH-sarcoma 19
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Evaluate the feasibility of using immunohistochemistry to detect the expression level of CDH6 in histological white slides of patients with osteosarcoma and Ewing's sarcoma as a biological marker for prognostic monitoring The patient's initial visit was clinically diagnosed as high-grade osteosarcoma or Ewing's sarcoma. The informed consent form for specimen monitoring was signed first. During the puncture biopsy, fresh tissue (soft tissue component, not bone tissue) with a volume of about 1cm3 was taken, fixed with formalin solution, and tissue slices (white slices) with a thickness of 5 microns were cut, smeared, and baked. Immunohistochemistry staining was used for CDH6 expression analysis (XP) ® Cadherin-6 (D3T3I) Rabbit mAb Cat:#48111, CellSignaling Technology）。
2. 2.Treatment process and follow-up The routine neoadjuvant chemotherapy regimen for osteosarcoma in our center includes sequential use of cisplatin, high-dose doxorubicin, methotrexate, and ifosfamide, while the VDC-IE regimen is used for Ewing sarcoma (see Figure 3.1.1A, B for details). Due to the significant heterogeneity of osteosarcoma cells, the subpopulations of cells affected by each drug are not the same, and there are also differences in the subpopulations of necrotic and lysed cells after medication. The expression level of CDH6 in patient tissue slices will dynamically change with the sensitivity of chemotherapy. While conducting clinical evaluations, if given the opportunity, we will try to compare the changes in CDH6 levels in tissue sections to assess their value for efficacy monitoring.
3. 3.We will use FFPE tumor tissue samples for immunohistochemical staining to analyze the expression of CDH6, β - catenin, and CDH17 in tumor tissue.

Conditions

Sarcoma; Sarcoma, Bone; Ewing Sarcoma; Osteosarcoma

Keywords

sarcoma; CDH6; Immunohistochemistry; prognosis; Biological markers

Outcome Measures

Primary Outcomes (1)

• CDH6 protein expression

  Immunochemotherapy

  Baseline

Secondary Outcomes (1)

• tumor necrosis rate

  Within 24 hours after surgery

Study Arms (2)

prechemotherapy

Puncture biopsy or surgical specimens of newly diagnosed patients before chemotherapy

post-chemotherapy

Conventional chemotherapy regimen

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

70 patients with osteosarcoma or Ewing's sarcoma

You may qualify if:

• Over 12 years old.
• High grade osteosarcoma or Ewing's sarcoma confirmed by clinical judgment or histopathology. Patients with local tumors and isolated lesions in the lungs must obtain pathological diagnosis confirmation, while multiple metastases in the lungs do not require pathological examination.
• Newly diagnosed patients who have not received formal first-line chemotherapy for osteosarcoma or Ewing's sarcoma. (First line chemotherapy drugs include high-dose methotrexate, anthracyclines, cisplatin, and ifosfamide; the first-line treatment regimen for Ewing's sarcoma is VDC sequential IE.)
• All other examination indicators suggest that standardized chemotherapy and surgical treatment for bone tumors can be accepted.

You may not qualify if:

• Cannot accept standardized chemotherapy and surgical treatment for bone tumors in our center.
• Not accepting standardized diagnosis and treatment routine follow-up.
• The researcher believes that there are any conditions that may harm the subjects or cause them to be unable to meet or perform the research requirements.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sarcomatous tissue used for immunohistochemistry

MeSH Terms

Conditions

Sarcoma; Osteosarcoma; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician, associate professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 27, 2025
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)