An Organoid-based Functional Precision Medicine Trial in Osteosarcoma

NCT ID: NCT06064682

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2028-01-01

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.

Detailed Description

Investigators successfully established a miniaturized system that allows the setup of hundreds of wells and perform assays with minimal manipulation. The adapted geometry used to plate tumor cells in Matrigel, to generate mini-rings around the rim of the wells. This is attained by plating single-cell suspensions obtained from a cell line or a surgical specimen pre-mixed with cold Matrigel in a ring shape around the rim in 96-well plates. Rings can be established using a single-well or multichannel pipette. Cancer cell lines grown in mini-ring format give rise to organized tumor organoids that recapitulate features of the original histology. Treatment protocols and readouts for the mini-ring approach have been optimized. Seeding cells takes place on day 0, 2-3 days are allowed to establish organoids and it is followed by two consecutive daily drug treatments. The assay is flexible and can be easily adapted to single treatments followed by longer incubations, multiple consecutive recurring treatments, multi-drug combinations, or other screening strategies. Assays were implemented to quantify drug response by measuring cell viability after staining of live organoids with specific dyes followed by imaging. The pipeline has been extended to sarcomas: the team characterized organoids established from over 120 sarcoma biopsies, resections, and metastasectomies. Sarcoma organoids showed patient-specific growth characteristics and subtype-specific histopathology. Organoid sensitivity correlated with diagnostic subtype, patient age at diagnosis, lesion type, prior treatment history, and disease trajectory for a subset of the compounds screened. Organoid screening can provide information to facilitate optimal drug selection, avoid ineffective therapies, and mirror patient outcomes in sarcoma.

Conditions

Osteosarcoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

standard of care biopsy

Intervention Type: OTHER

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

Group 2: metastatic disease

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

standard of care biopsy

Intervention Type: OTHER

Image-guided or surgical biopsy or excision of the lesion that is suspected to be recurrent or metastatic osteosarcoma (Group 2).

Interventions

standard of care biopsy

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

Intervention Type: OTHER

standard of care biopsy

Image-guided or surgical biopsy or excision of the lesion that is suspected to be recurrent or metastatic osteosarcoma (Group 2).

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Soragni, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Summer Swearingen

Role: CONTACT

SSwearingen@mednet.ucla.edu

(424) 766-9349

Facility Contacts

Summer Swearingen

Role: primary

SSwearingen@mednet.ucla.edu

424-766-9349

Other Identifiers

23-001212

Identifier Type: -

Identifier Source: org_study_id