Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD
1 other identifier
interventional
340
1 country
15
Brief Summary
This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2018
CompletedFirst Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
May 5, 2026
April 1, 2026
8.7 years
September 28, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free survival rate
Proportion of patient without an event by baseline detection of ctDNA
2 years
Secondary Outcomes (1)
Event-free survival rate
2 years
Study Arms (2)
REG EWING or OSTEO: ctDNA EVALUATION
NO INTERVENTIONThis 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
EXPERIMENTALThis 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +1 more criteria
You may not qualify if:
- 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
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alex's Lemonade Stand Foundationcollaborator
- Harvard Universitycollaborator
- Conquer Cancer Foundationcollaborator
- Sam Day Foundationcollaborator
- Dana-Farber Cancer Institutelead
Study Sites (15)
Childrens Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Children's Hospital's and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Lifespan / Rhode Island Hospital
Providence, Rhode Island, 02903, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Utah Childrens Medical Center
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David S Shulman, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 28, 2023
First Posted
October 5, 2023
Study Start
May 8, 2018
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.