Liquid Biopsy for Bone Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen by David S Shulman, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must be taking: Chemotherapy

Disqualifiers: Metastatic disease, Ewing-like sarcoma, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a blood test that looks for small pieces of tumor DNA in patients with Ewing sarcoma or osteosarcoma. The goal is to see if this test can help predict if the cancer will return after treatment. A group of patients will participate to help researchers understand how useful this test can be.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on patients who have not yet started chemotherapy or radiation therapy, or those who have a pre-treatment sample available.

What data supports the effectiveness of the treatment FoundationOne Liquid CDx for bone cancer?

Research shows that FoundationOne Liquid CDx can identify targetable mutations in high-risk cancers, including bone sarcoma, which can guide treatment decisions. Liquid biopsies, like FoundationOne Liquid CDx, are effective in other cancers for monitoring therapy and identifying treatment targets, suggesting potential benefits for bone cancer as well. ^{1 2 3 4 5}

How is the liquid biopsy treatment for bone cancer different from other treatments?

Liquid biopsy is unique because it uses a simple blood or urine test to detect cancer-related molecules, making it less invasive and painful than traditional tissue biopsies. This approach can help monitor the cancer in real-time and guide treatment decisions without the need for surgical procedures. ^{2 3 5 6 7}

Research Team

David S Shulman, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

The LEOPARD trial is for individuals aged 12 months to 50 years with a new diagnosis of Ewing sarcoma or high-grade osteosarcoma, who have not started or just begun treatment. It's not for those with distant metastatic disease, other types of sarcomas, complete tumor resection before joining the study, pelvic primary tumors in osteosarcoma patients, or if pregnant.

Inclusion Criteria

I have received previous treatments for my condition.

I am scheduled to receive chemotherapy.

I am between 1 year and 50 years old.

Exclusion Criteria

For Part B, subjects must not meet any of the following exclusion criteria.

Resides outside of the United States

Pregnancy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: ctDNA Evaluation

Participants provide blood samples at pre-defined times to evaluate ctDNA for genetic alterations in Ewing sarcoma or osteosarcoma.

6 months

Multiple visits for blood sample collection

Part B: ctDNA Return of Results

Participants provide blood samples for ctDNA testing, with results returned to providers and patients.

6 months

Multiple visits for blood sample collection

Follow-up

Participants are monitored for event-free survival and other outcomes after the main study phases.

2 years

Treatment Details

Interventions

• FoundationOne Liquid CDx (Cancer Biomarker Test)

Trial Overview This trial tests the use of FoundationOne Liquid CDx liquid biopsy to see how well it predicts outcomes and monitors response to therapy in patients with Ewing sarcoma or osteosarcoma. Participants will be monitored over time to assess changes in ctDNA levels.

Participant Groups

Group I: EWING ctDNA RETURN OF RESULTS Experimental Treatment 1 Intervention

This study involves collection of blood samples at pre-specified time points as well as collection of information about this disease. For each timepoint, submit two tubes of blood (17 mL total or a little more than 3 teaspoons) to a commercial testing laboratory called Foundation Medicine and one tube of blood (10 mL or 2 teaspoons) to standard ctDNA workflow

Group II: REG EWING or OSTEO: ctDNA EVALUATION Active Control 1 Intervention

This study involves collection of blood samples at pre-specified time points as well as collection of information about this disease. For each timepoint, submit two tubes of blood (17 mL total or a little more than 3 teaspoons) per standard ctDNA workflow

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Seattle Children's Hospital Seattle, WA

Childrens Hospital Los Angeles Los Angeles, CA

Children's Healthcare of Atlanta Atlanta, GA

Massachusetts General Hospital Cancer Center Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1128

Patients Recruited

382,000+

Conquer Cancer Foundation

Collaborator

Trials

22

Patients Recruited

4,000+

Alex's Lemonade Stand Foundation

Industry Sponsor

Trials

9

Patients Recruited

1,500+

Harvard University

Collaborator

Trials

237

Patients Recruited

588,000+

Sam Day Foundation

Collaborator

Trials

1

Patients Recruited

340+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-Derived Liquid Biopsies Using Foundation One&#174; Liquid CDx for Children and Adolescents with High-Risk Malignancies: A Monocentric Experience. Cahn, F., Revon-Riviere, G., Min, V., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid biopsies in primary and secondary bone cancers. Ucci, A., Rucci, N., Ponzetti, M.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Perspective and Translational Oncology of Liquid Biopsy. Fernández-Lázaro, D., Hernández, JLG., García, AC., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid Biopsy in Colorectal Cancer: Quo Vadis? Implementation of Liquid Biopsies in Routine Clinical Patient Care in Two German Comprehensive Cancer Centers. Fischer, LE., Stintzing, S., Heinemann, V., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid Biopsy in Solid Malignancy. Scarlotta, M., Simsek, C., Kim, AK.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid biopsies in pediatric oncology: opportunities and obstacles. Sundby, RT., Pan, A., Shern, JF.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for a practical implementation of circulating tumor DNA mutation testing in metastatic non-small-cell lung cancer. Heitzer, E., van den Broek, D., Denis, MG., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Blood-Derived Liquid Biopsies Using Foundation One&#174; Liquid CDx for Children and Adolescents with High-Risk Malignancies: A Monocentric Experience. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Liquid biopsies in primary and secondary bone cancers. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Perspective and Translational Oncology of Liquid Biopsy. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Liquid Biopsy in Colorectal Cancer: Quo Vadis? Implementation of Liquid Biopsies in Routine Clinical Patient Care in Two German Comprehensive Cancer Centers. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Liquid Biopsy in Solid Malignancy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Liquid biopsies in pediatric oncology: opportunities and obstacles. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Recommendations for a practical implementation of circulating tumor DNA mutation testing in metastatic non-small-cell lung cancer. [2022]