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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a liquid biopsy (a blood test) can predict outcomes in individuals with Ewing sarcoma or osteosarcoma, both types of bone cancer. Researchers collect blood samples at various times to identify specific markers that might provide doctors with more information about the cancer. The trial uses FoundationOne Liquid CDx, a specific liquid biopsy, to analyze these markers. It is suitable for individuals newly diagnosed with Ewing sarcoma or high-grade osteosarcoma that has not spread to distant parts of the body and who have not yet started chemotherapy or radiation. Participants will provide blood samples, and doctors will collect data about their disease. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future cancer care.

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 prior data suggests that this liquid biopsy method is safe for patients with bone cancer?

Research has shown that FoundationOne Liquid CDx is safe for people. The FDA has already approved this test for certain conditions, indicating it has passed safety checks for those uses. Studies have demonstrated its effectiveness as a companion diagnostic, helping doctors choose treatments by analyzing genes from a blood sample.

Previous studies tested it in people with high-risk solid tumors and found it feasible, meaning patients tolerated it well. These studies reported no serious safety issues. Overall, the available data suggest that FoundationOne Liquid CDx is a safe option for analyzing specific cancer markers in the blood. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using a liquid biopsy technique to detect and monitor bone cancer through ctDNA, which is circulating tumor DNA found in the blood. Unlike traditional methods that rely on invasive tissue biopsies, this approach uses a simple blood draw to gather information about the cancer. This could lead to quicker, less painful, and more frequent monitoring of the disease, potentially allowing for more personalized and timely treatment adjustments. By using FoundationOne Liquid CDx, researchers aim to better understand the genetic landscape of the cancer, which could open doors to targeted therapy options and improve patient outcomes.

What evidence suggests that this trial's method of using FoundationOne Liquid CDx for detecting ctDNA is effective for bone cancer?

Research has shown that FoundationOne Liquid CDx effectively identifies cancer-related genetic changes in the blood. This test examines 324 cancer-linked genes, enabling doctors to understand the tumor's genetic details without a tissue sample. Studies have demonstrated its success in detecting genetic markers across various solid tumors. The test aids in selecting treatments, particularly when obtaining tissue samples is challenging. It has proven useful in identifying specific gene changes that may respond well to certain cancer treatments. Although the test does not treat cancer, it provides crucial information for disease management. In this trial, participants will have their blood samples collected and analyzed using FoundationOne Liquid CDx to evaluate circulating tumor DNA (ctDNA) as part of the study's investigation into bone cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

David S Shulman, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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 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) 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9179410/

Blood-Derived Liquid Biopsies Using Foundation One ... Molecular profiling using Foundation One® Liquid CDx was feasible in pediatric patients with high-risk solid tumors and lead to identification ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190032B.pdf

summary of safety and effectiveness data (ssed) Effectiveness Results (Concordance):. The concordance of BRCA status between FoundationOne Liquid CDx and. CTA test results were evaluated for all patients ...

3. info.foundationmedicine.com info.foundationmedicine.com/hubfs/FMI%20Labels/FoundationOne_CDx_Label_Technical_Info.pdf

Page 1 of 110 FoundationOne®CDx Technical Information ... Clinical efficacy results in the CDx-positive population for solid tumor patients with. NTRK1, 2, 3 fusions treated with entrectinib. The clinical efficacy of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8926248/

Clinical and analytical validation of FoundationOne®CDx, a ... F1CDx is an FDA-approved NGS-based in vitro diagnostic device that targets 324 cancer-related genes. F1CDx is performed exclusively by ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200016B.pdf

summary of safety and effectiveness data (ssed) On October 26, 2020 the FoundationOne® Liquid CDx test was approved as a companion diagnostic for BRCA1 and BRCA2 alterations in epithelial.

6. foundationmedicine.com foundationmedicine.com/test/foundationone-liquid-cdx

FoundationOne Liquid CDx FoundationOne Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw.