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Blood test could revolutionize sarcoma monitoring

NCT ID NCT06068075

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a liquid biopsy (a blood test that detects tumor DNA) can help predict outcomes for people with Ewing sarcoma or osteosarcoma. Researchers will collect blood samples from 340 patients at diagnosis and track their health over time. The goal is to see if the amount of tumor DNA in the blood can tell doctors how aggressive the cancer is and how well treatment is working.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liquid biopsy (FoundationOne Liquid CDx test)
What this could lead to
If successful, this could lead to a simple blood test that helps doctors predict how aggressive a sarcoma is and whether treatment is working, without needing repeated tissue biopsies.
What could go wrong
This is an observational study, not a treatment trial. The test may not prove accurate enough to change patient care, and results may not apply to all sarcoma types or stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 months to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital's and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027-0700, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Lifespan / Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, 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

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