Liquid Biopsy for Bone Cancer

Recruiting at 14 trial locations

Overseen By David S. Shulman, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Chemotherapy

Disqualifiers: Metastatic disease, Ewing-like sarcoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

340 Participants Needed

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

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

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Conquer Cancer Foundation

Collaborator

Trials

22

Recruited

4,000+

Alex's Lemonade Stand Foundation

Industry Sponsor

Trials

9

Recruited

1,500+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Sam Day Foundation

Collaborator

Trials

1

Recruited

340+

Findings from Research

A study involving 45 pediatric patients with relapsing or refractory solid tumors demonstrated that liquid biopsy using Foundation One® Liquid CDx is a feasible method for molecular profiling, successfully identifying targetable mutations in 25 samples.

Out of the patients analyzed, 6 received treatment based on liquid biopsy results, leading to one patient achieving stable disease for eight months, highlighting the potential of liquid biopsies in guiding treatment decisions in pediatric oncology.

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]

Liquid biopsies offer a non-invasive method to analyze tumor characteristics and progression in bone cancers, which is crucial since traditional biopsies can be painful and risky.

Recent advances in liquid biopsies, including the use of circulating tumor cells and cell-free DNA, show promise for improving diagnosis and treatment decisions in both primary and secondary bone cancers, although challenges like cost and reproducibility remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Liquid biopsy (LB) is a promising method for cancer detection and monitoring, as it analyzes circulating tumor cells and nucleic acids in biofluids, overcoming the limitations of traditional tissue biopsies.

LB has shown effectiveness across various cancer types, including lung, colorectal, and breast cancers, by identifying biomarkers that can help predict disease progression and tailor treatment strategies.

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]

Liquid biopsies (LB) have the potential to guide personalized treatment and monitor disease in colorectal cancer (CRC) patients, but their clinical use is not fully realized, as shown in a study of 86 CRC patients at two German cancer centers from 2017 to 2021.

In this study, there was a significant divergence (39%) in RAS status between tissue-based and liquid-based diagnostics, highlighting the need for standardization and further research to improve the implementation of LB in routine clinical practice.

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]

Liquid biopsies, which analyze biofluids like blood or urine for tumor-related molecules, are emerging as valuable tools in cancer management, potentially serving as alternatives to traditional tissue biopsies.

This review highlights three key methods of liquid biopsy—circulating tumor cells, extracellular vesicles, and circulating tumor DNA—demonstrating their diagnostic and prognostic potential in assessing cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Liquid biopsies, which analyze cell-free DNA from blood, offer a noninvasive way to monitor and treat pediatric cancers, providing insights at diagnosis and during treatment without the need for anesthesia or invasive procedures.

Despite challenges like limited blood volume and low mutation rates in childhood cancers, advancements in multiomic approaches and bioinformatics are enhancing the effectiveness and applicability of liquid biopsies in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Liquid biopsy (LB), particularly through circulating tumor DNA (ctDNA) testing, is emerging as a valuable tool in precision oncology for metastatic non-small-cell lung cancer (NSCLC), providing insights into actionable targets for therapy selection.

ctDNA mutation testing can complement traditional tissue biopsy (TB) by identifying resistance mechanisms and potential targets that may be missed in tissue samples, especially in cases where tumor location makes biopsy difficult or when samples are insufficient.

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]