RECRUITING

Liquid Biopsy in Ewing Sarcoma and Osteosarcoma As a Prognostic and Response Diagnostic: LEOPARD

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Conditions

Ewing SarcomaEwing Sarcoma of BoneEwing Sarcoma of Soft TissuePeripheral Primitive Neuroectodermal TumorPeripheral Primitive Neuroectodermal Tumor of BonePeripheral Primitive Neuroectodermal Tumor of Soft TissueHigh-grade Osteosarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective multicenter biomarker study evaluating the prognostic impact of ctDNA detection at diagnosis in patients with Ewing sarcoma or osteosarcoma.

Official Title

Liquid Biopsy in Ewing Sarcoma and Osteosarcoma As a Prognostic and Response Diagnostic: the LEOPARD Study

Quick Facts

Study Start:2018-05-08
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06068075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * For Part A, subjects must meet all of the following eligibility criteria.
  2. * Age: ≥ 12 months of age at time of study enrollment to 50 years of age
  3. * 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.
  4. * Prior Therapy:
  5. * Patients should have only previously had a biopsy, and not had prior attempt at tumor resection.
  6. * 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.
  7. * Planned to receive chemotherapy as follows:
  8. * For Part B subjects must meet all of the following eligibility criteria.
  9. * Age: ≥ 12 months of age at time of study enrollment
  10. * Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue
  11. * Prior Therapy:
  12. * Patients should have had only frontline therapy as per institutional standard, and maintenance therapy if given (no relapse therapy).
  13. * If frontline systemic therapy already completed (not including maintenance or metastatic site radiation), therapy completed within 6 months of enrollment to Part B.
  14. * Subjects must have a willing physician provider supporting their participation in Part B.
  15. * 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.
  1. * For Part A, subjects must not meet any of the following exclusion criteria.
  2. * Patients with distant metastatic disease.
  3. * Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible.
  4. * 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.
  5. * Patients weighing \< 5 kg at time of diagnosis
  6. * Patients with a second malignant neoplasm
  7. * Patients without detectable tumor at the time of study enrollment (ie, complete tumor resection prior to study enrollment)
  8. * 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.
  9. * Patients with osteosarcoma with a pelvic primary tumor site Pregnancy
  10. * For Part B, subjects must not meet any of the following exclusion criteria.
  11. * Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible.
  12. * 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
  13. * Patients weighing \< 5 kg at time of enrollment
  14. * Patients diagnosed with relapsed disease and/or having started therapy directed at disease relapse
  15. * Pregnancy
  16. * Resides outside of the United States
  17. * For Part B, providers at non-study centers will not be eligible to receive the provider survey.

Contacts and Locations

Study Contact

David S. Shulman, MD
CONTACT
617-632-6670
david_shulman@dfci.harvard.edu

Principal Investigator

David S Shulman, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • David S Shulman, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-08
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2018-05-08
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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