← Back to Search

Liquid Biopsy for Bone Cancer

N/A

Recruiting

Led By David S Shulman, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial looks at biomarkers in Ewing and osteosarcoma to help predict their progression.

Who is the study for?

The LEOPARD trial is for individuals aged 12 months to 50 years with a new diagnosis of Ewing sarcoma or high-grade osteosarcoma, who have not started or just begun treatment. It's not for those with distant metastatic disease, other types of sarcomas, complete tumor resection before joining the study, pelvic primary tumors in osteosarcoma patients, or if pregnant.Check my eligibility

What is being tested?

This trial tests the use of FoundationOne Liquid CDx liquid biopsy to see how well it predicts outcomes and monitors response to therapy in patients with Ewing sarcoma or osteosarcoma. Participants will be monitored over time to assess changes in ctDNA levels.See study design

What are the potential side effects?

As this is a diagnostic study focusing on liquid biopsies rather than drug treatments, there are no direct side effects from the intervention being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 1 year and 50 years old.

Select...

I have been diagnosed with Ewing sarcoma, PNET, or high-grade osteosarcoma that is not in my pelvis.

Select...

I have only had a biopsy, no surgery to remove my tumor.

Select...

I am scheduled to receive chemotherapy.

Select...

I have been diagnosed with Ewing sarcoma or PNET of bone or soft tissue.

Select...

I am receiving specific chemotherapy protocols for Ewing sarcoma or osteosarcoma.

Select...

I am at least 1 year old.

Select...

I have only received the first round of treatment for my condition, and maintenance therapy if it was given.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Event-free survival rate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EWING ctDNA RETURN OF RESULTSExperimental Treatment1 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) to a commercial testing laboratory called Foundation Medicine and one tube of blood (10 mL or 2 teaspoons) to standard ctDNA workflow

Group II: REG EWING or OSTEO: ctDNA EVALUATIONActive Control1 Intervention

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Conquer Cancer FoundationOTHER

19 Previous Clinical Trials

3,635 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,640 Total Patients Enrolled

Alex's Lemonade Stand FoundationIndustry Sponsor

7 Previous Clinical Trials

1,103 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adolescents within the age range of eligibility for this research program?

"As detailed in the prerequisites for this trial, only individuals aged between 12 months and 50 are eligible to take part."

Answered by AI

Do I meet the prerequisites to join this medical research project?

"For eligibility, applicants must be diagnosed with ewing sarcoma and aged between 12 months to 50 years. The total slots available for this trial are 150 participants."

Answered by AI

How many enrollees are currently enrolled in this experiment?

"To successfully complete this study, 150 eligible individuals are necessary. The sponsor of the trial is Alex's Lemonade Stand Foundation and it will be undertaken in multiple centres such as Children's Healthcare of Atlanta (Atlanta, Georgia) and Massachusetts General Hospital Cancer Center (Boston)."

Answered by AI

Are new participants being welcomed into this research project?

"The clinical trial is open for recruitment, as evidenced by the details posted on clinicaltrials.gov - which shows that this study was initially listed on May 8th 2018 and last updated September 28th 2023."

Answered by AI

Could you detail how many Canadian sites are conducting this trial?

"There are 15 sites participating in this trial, located across the United States. These include Children's Healthcare of Atlanta in Georgia, Massachusetts General Hospital Cancer Center and Boston Children's Hospital both situated in Boston as well as a variety other medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

David S Shulman, MD 2018. "Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06068075.

All > Osteosarcoma > Bone Cancer