An Organoid-based Functional Precision Medicine Trial in Osteosarcoma

NCT06064682 | Recruiting

• 1 other identifier: 23-001212
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine if we can predict sensitivity of osteosarcoma to different chemotherapy agents using tissue cultures in the laboratory. We know that different chemotherapy agents can be used in the treatment, but not every sarcoma responds to them equally. It is important to understand if testing of the tissue obtained during a routine biopsy or surgery may be useful in selecting appropriate treatments. In addition, additional testing of the tumor, including genetic testing, will help us to understand osteosarcoma better.

Conditions

Osteosarcoma

Keywords

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• organoids from initial biopsy

  To assess the feasibility of establishing organoids from initial biopsy and from postsurgical sample in patients with osteosarcoma, both in patients with localized disease and metastatic disease

  two years

Secondary Outcomes (3)

• drug sensitivity of organoids

  two years

• degree of necrosis in the tumor

  two years

• clinical benefit

  two years

Study Arms (2)

Group 1: local tumor

patients with localized osteosarcoma who are scheduled to undergo diagnostic biopsy and are planned for surgical excision of the primary tumor

Other: standard of care biopsy

Group 2: metastatic disease

patients with metastatic osteosarcoma who are scheduled to undergo either biopsy or surgery of metastatic disease

Other: standard of care biopsy

Interventions

standard of care biopsy OTHER

Image-guided or surgical biopsy of the lesion that is suspected to be osteosarcoma in a patient with localized disease (Group 1)

Group 1: local tumor

Eligibility Criteria

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

Study Population

Osteosarcoma is the most common primary bone malignancy of childhood and adolescence with a bimodal age distribution and a secondary peak in the 6th and 7th decades of life. The standard of care for localized disease is neoadjuvant cytotoxic chemotherapy followed by primary resection and adjuvant cytotoxic chemotherapy. Introduction of chemotherapy in the treatment of patients with osteosarcoma resulted in a significant improvement in the overall survival, but further improvement is needed. Currently, 5-year survival rate is 65 - 70%; for de novo metastatic disease or recurrent disease, 5-year survival rate is \<30%. Recurrent or metastatic osteosarcomas are usually resistant to standard of care, and treatment options for refractory osteosarcomas are extremely limited.

You may not qualify if:

• \- Patients without diagnosis of osteosarcoma and whose imaging studies are suggestive of osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes
• \- Patients whose imaging studies are suggestive of metastatic osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Alice Soragni, PhD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Summer Swearingen

CONTACT

(424) 766-9349; SSwearingen@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2025-03

Locations

US (1)