Trial Title:
Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD
NCT ID:
NCT06068075
Condition:
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
Conditions: Official terms:
Neoplasms
Sarcoma
Osteosarcoma
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Bone Neoplasms
Soft Tissue Neoplasms
Conditions: 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
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
FoundationOne Liquid CDx
Description:
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
Arm group label:
EWING ctDNA RETURN OF RESULTS
Other name:
Liquid Biopsy
Summary:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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.
Gender:
All
Minimum age:
12 Months
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Childrens Hospital Los Angeles
Address:
City:
Los Angeles
Zip:
90027-0700
Country:
United States
Status:
Recruiting
Facility:
Name:
Children's Healthcare of Atlanta
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Edwin Choy, MD
Email:
echoy@partners.org
Investigator:
Last name:
Edwin Choy, MD
Email:
Principal Investigator
Facility:
Name:
Boston Children's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Shulman, MD
Phone:
617-632-6670
Investigator:
Last name:
David Shulman, MD
Email:
Principal Investigator
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pricilla Merriam, MD
Phone:
617-632-5204
Investigator:
Last name:
Pricilla Merriam, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
David S Shulman, MD
Phone:
617-632-6670
Email:
david_shulman@dfci.harvard.edu
Investigator:
Last name:
David S Shulman, MD
Email:
Principal Investigator
Facility:
Name:
Children's Hospital's and Clinics of Minnesota
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kris Ann Schultz
Investigator:
Last name:
Kris Ann Schultz, MD
Email:
Principal Investigator
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229-3039
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Turpin, MD
Investigator:
Last name:
Brian Turpin, MD
Email:
Principal Investigator
Facility:
Name:
Nationwide Children's Hospital
Address:
City:
Columbus
Zip:
43205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bhuvana Setty, MD
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rochelle Bagatell, MD
Investigator:
Last name:
Rochelle Bagatell, MD
Email:
Principal Investigator
Facility:
Name:
Lifespan / Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bradley DeNardo, MD
Investigator:
Last name:
Bradley DeNardo, MD
Email:
Principal Investigator
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Bishop, MD
Investigator:
Last name:
Michael Bishop, MD
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Avanthi Shah, MD
Investigator:
Last name:
Avanthi Shah, MD
Email:
Principal Investigator
Facility:
Name:
University of Utah Childrens Medical Center
Address:
City:
Salt Lake City
Zip:
84113
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luke Maese, MD
Investigator:
Last name:
Luke Maese, MD
Email:
Principal Investigator
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Doug Hawkins, MD
Email:
Principal Investigator
Start date:
May 8, 2018
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Alex's Lemonade Stand Foundation
Agency class:
Industry
Collaborator:
Agency:
Conquer Cancer Foundation
Agency class:
Other
Collaborator:
Agency:
Harvard University
Agency class:
Other
Collaborator:
Agency:
Sam Day Foundation
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06068075
