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An Organoid-based Functional Precision Medicine Trial in Osteosarcoma

ConditionOsteosarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • standard of care biopsy

    Other intervention

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

  • standard of care biopsy

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1: local tumor1 intervention
Group B: Group 2: metastatic disease1 intervention

Trial outcomes

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

Time frame
two years

Secondary outcomes

1

drug sensitivity of organoids

To compare drug sensitivity of organoids established from the original biopsy to drug sensitivity of organoids established from the surgical excision of the primary tumor after neoadjuvant chemotherapy

Time frame
two years
2

degree of necrosis in the tumor

To correlate the degree of necrosis in the tumor obtained by the surgical excision of the primary tumor after neoadjuvant chemotherapy with the chemotherapeutic drug sensitivity in the organoids.

Time frame
two years
3

clinical benefit

To correlate the magnitude of clinical benefit in patients with metastatic osteosarcoma treated with systemic chemotherapy with the chemotherapeutic drug sensitivity in the organoids established from biopsy or surgical excision of metastatic disease.

Time frame
two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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