Ewing SarcomaNCT06068075
Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD
A study testing FoundationOne Liquid CDx in people with Ewing Sarcoma and Ewing Sarcoma of Bone, run by Dana-Farber Cancer Institute at 15 sites in United States.
Trial summary
This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma. Read more about this study
- Who is it for?
- Ages 12 months to 50 years
- Conditions the study is for
- Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue
- What is being tested?
- FoundationOne Liquid CDx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 15 sitesUnited States
- Study dates
- 8 May 2018to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For Part A, subjects must meet all of the following eligibility criteria.
- Age: ≥ 12 months of age at time of study enrollment to 50 years of age
- Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, localized or regionally disseminated Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue or; Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, non-pelvic, localized or regionally disseminated high-grade osteosarcoma. NOTE: Staging will be assessed according to standard of care at the treating center.
- Prior Therapy:
- Patients should have only previously had a biopsy, and not had prior attempt at tumor resection.
- Not yet started chemotherapy or radiation therapy OR patient has started chemotherapy or radiation therapy, but an appropriate pre-treatment baseline sample was collected and processed for ctDNA under a local banking study in DFCI Pediatrics and is available to use for this study.
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- Planned to receive chemotherapy as follows:
- -- VDC/IE as per COG protocols AEWS0031, AEWS1031 or AEWS1221 (for patients with Ewing sarcoma or PNET); or MAP as per COG protocol AOST0331 (for patients with osteosarcoma).
- For Part B subjects must meet all of the following eligibility criteria.
- Age: ≥ 12 months of age at time of study enrollment
- Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue
- Prior Therapy:
- Patients should have had only frontline therapy as per institutional standard, and maintenance therapy if given (no relapse therapy).
- If frontline systemic therapy already completed (not including maintenance or metastatic site radiation), therapy completed within 6 months of enrollment to Part B.
- Subjects must have a willing physician provider supporting their participation in Part B.
- For Part B, providers are eligible to receive the provider survey if they are listed as the primary provider for the patient at the study site.
Who cannot join
- For Part A, subjects must not meet any of the following exclusion criteria.
- Patients with distant metastatic disease.
- Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible.
- Patients who are enrolled with an initial diagnosis of Ewing sarcoma and subsequently found to have Ewing-like sarcoma will be replaced. Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol.
- Patients weighing < 5 kg at time of diagnosis
- Patients with a second malignant neoplasm
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- Patients without detectable tumor at the time of study enrollment (ie, complete tumor resection prior to study enrollment)
- Patients already receiving tumor-directed therapy at the time of study enrollment except when a pre-treatment baseline sample has already been obtained under a local banking study in DFCI Pediatrics that would be eligible for analysis under this study.
- Patients with osteosarcoma with a pelvic primary tumor site Pregnancy
- For Part B, subjects must not meet any of the following exclusion criteria.
- Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible.
- Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol
- Patients weighing < 5 kg at time of enrollment
- Patients diagnosed with relapsed disease and/or having started therapy directed at disease relapse
- Pregnancy
- Resides outside of the United States
- For Part B, providers at non-study centers will not be eligible to receive the provider survey.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center
Dallas, Texas, 75390
Childrens Hospital Los Angeles
Los Angeles, California, 90027-0700
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Children's Hospital's and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Lifespan / Rhode Island Hospital
Providence, Rhode Island, 02903
University of Utah Childrens Medical Center
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: The LEOPARD Study
This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma.
Read the detailed description
The purpose of this study is to evaluate whether ctDNA in the blood can provide information about the chances of Ewing sarcoma or osteosarcoma coming back after treatment. This research study is evaluating a new advanced laboratory test to detect small pieces of tumor genes in the peripheral blood known as circulating tumor DNA (ctDNA).
Part A : During this part of the research study (Part A) participants will be asked to provide blood samples at pre-defined times. These blood samples may help find specific genetic alterations commonly seen in Ewing sarcoma or osteosarcoma that may allow investigators to learn more about the uses of ctDNA. The results of the ctDNA analysis will not be returned to participants.
Approximately 90 patients will take part in this study across multiple centers.
Part B: This research study is evaluating new advanced laboratory tests to detect small pieces of tumor genes in the peripheral blood known as circulating tumor DNA (ctDNA). Part B of the research study, which focuses on ctDNA tests that can be returned to providers and patients with Ewing sarcoma. This part of the study will allow comparison of commercial ctDNA testing from Foundation Medicine to our research testing. It is expected that about 60 people with Ewing sarcoma will take part in Part B of this research study.
The sponsor of this protocol is Dana-Farber Cancer Institute and is providing funding for the study. Additional funding for this study is provided by the Conquer Cancer Foundation of the American Society of Clinical Oncology, Alex's Lemonade Stand Foundation, Boston Children's Hospital Office of Faculty Development, the Friends of Dana-Farber Cancer Institute, The Harvard Catalyst Program, and the Spada Pediatric Sarcoma Foundation
- Conditions
- Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue, Peripheral Primitive Neuroectodermal Tumor, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissue
- Being tested
- FoundationOne Liquid CDx
- Keywords
- Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue, Peripheral Primitive Neuroectodermal Tumor, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissue, High-grade osteosarcoma
- Medical subject headings
- Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoundationOne Liquid CDxOther
Also called Liquid Biopsy
a FoundationOne liquid biopsy test kit will be sent to the laboratory of the subject's treating center, in addition to the paired cell stabilizing tube from the primary center
| Study group | Role | What they receive |
|---|---|---|
| REG EWING or OSTEO: ctDNA EVALUATION | No 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 |
| EWING ctDNA RETURN OF RESULTS | Experimental | 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 Receives: Other: FoundationOne Liquid CDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival rate
Proportion of patient without an event by baseline detection of ctDNA
Measured: 2 years
Secondary outcomes (1)
Event-free survival rate
Proportion of patient without an event by ctDNA burden at baseline
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start8 May 2018
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alex's Lemonade Stand Foundation, Conquer Cancer Foundation, Harvard University, Sam Day Foundation
- Responsible party
- Principal investigator, David S Shulman, MD, Dana-Farber Cancer Institute
- Investigators
- David S Shulman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068075
- Sponsor's protocol ID
- 18-138
- Status last verified
- Apr 2026
- First submitted
- 28 Sep 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: The LEOPARD Study
- ClinicalTrials.gov ID
- NCT06068075
- Acronym / sponsor ID
- 18-138
- Conditions
- Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue, Peripheral Primitive Neuroectodermal Tumor, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissue
- Keywords
- Ewing Sarcoma, Ewing Sarcoma of Bone, Ewing Sarcoma of Soft Tissue, Peripheral Primitive Neuroectodermal Tumor, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissue, High-grade osteosarcoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Alex's Lemonade Stand Foundation, Conquer Cancer Foundation, Harvard University, Sam Day Foundation
- Study start
- 8 May 2018 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma.
Detailed description
The purpose of this study is to evaluate whether ctDNA in the blood can provide information about the chances of Ewing sarcoma or osteosarcoma coming back after treatment. This research study is evaluating a new advanced laboratory test to detect small pieces of tumor genes in the peripheral blood known as circulating tumor DNA (ctDNA).
Part A : During this part of the research study (Part A) participants will be asked to provide blood samples at pre-defined times. These blood samples may help find specific genetic alterations commonly seen in Ewing sarcoma or osteosarcoma that may allow investigators to learn more about the uses of ctDNA. The results of the ctDNA analysis will not be returned to participants.
Approximately 90 patients will take part in this study across multiple centers.
Part B: This research study is evaluating new advanced laboratory tests to detect small pieces of tumor genes in the peripheral blood known as circulating tumor DNA (ctDNA). Part B of the research study, which focuses on ctDNA tests that can be returned to providers and patients with Ewing sarcoma. This part of the study will allow comparison of commercial ctDNA testing from Foundation Medicine to our research testing. It is expected that about 60 people with Ewing sarcoma will take part in Part B of this research study.
The sponsor of this protocol is Dana-Farber Cancer Institute and is providing funding for the study. Additional funding for this study is provided by the Conquer Cancer Foundation of the American Society of Clinical Oncology, Alex's Lemonade Stand Foundation, Boston Children's Hospital Office of Faculty Development, the Friends of Dana-Farber Cancer Institute, The Harvard Catalyst Program, and the Spada Pediatric Sarcoma Foundation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REG EWING or OSTEO: ctDNA EVALUATION | No 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 |
| EWING ctDNA RETURN OF RESULTS | Experimental | Other: FoundationOne Liquid CDxThis 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 |
Who may qualify
- Ages
- 12 months to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- For Part A, subjects must meet all of the following eligibility criteria.
- Age: ≥ 12 months of age at time of study enrollment to 50 years of age
- Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, localized or regionally disseminated Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue or; Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, non-pelvic, localized or regionally disseminated high-grade osteosarcoma. NOTE: Staging will be assessed according to standard of care at the treating center.
- Prior Therapy:
- Planned to receive chemotherapy as follows:
Key exclusion criteria (17 listed)
- For Part A, subjects must not meet any of the following exclusion criteria.
- Patients with distant metastatic disease.
- Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible.
- Patients who are enrolled with an initial diagnosis of Ewing sarcoma and subsequently found to have Ewing-like sarcoma will be replaced. Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol.
- Patients weighing < 5 kg at time of diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoundationOne Liquid CDxAlso: Liquid Biopsya FoundationOne liquid biopsy test kit will be sent to the laboratory of the subject's treating center, in addition to the paired cell stabilizing tube from the primary center | Other | EWING ctDNA RETURN OF RESULTS |
Primary outcome
Event-free survival rate
Time frame: 2 years
Proportion of patient without an event by baseline detection of ctDNA
1 secondary outcome
Event-free survival rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Ewing Sarcoma
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Metastatic Ewing Sarcoma, Metastatic Malignant Neoplasm in the Bone
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CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
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Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
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Active, not recruitingPhase 2
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
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XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Shulman, MD principal investigator
Dana-Farber Cancer Institute
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoundationOne Liquid CDx in people with Ewing Sarcoma and Ewing Sarcoma of Bone, run by Dana-Farber Cancer Institute at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.