Liquid biopsy (ctDNA) blood test for bone and soft tissue sarcoma
Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients
This study will test whether low-pass whole genome sequencing of a blood liquid biopsy can detect tumor DNA in adults and children with bone or soft tissue sarcomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT06958107 on ClinicalTrials.gov |
What this trial studies
This observational study will collect blood samples from adult and pediatric patients with suspected or confirmed bone and soft tissue sarcomas, including lipomatous lesions like ALT/WDLS. Investigators will use low-pass whole genome sequencing (LP-WGS) to search for circulating tumor DNA (ctDNA) and compare those findings with clinical status, imaging, and pathology. The study includes patients across disease states: non-metastatic resectable, metastatic unresectable, and patients under surveillance after therapy. The aim is to see if LP-WGS liquid biopsy can support diagnosis, prognosis, treatment monitoring, and early detection of recurrence in sarcoma patients.
Who should consider this trial
Good fit: People of any age with suspected or confirmed bone or soft tissue sarcoma (including suspected ALT/WDLS) who can come to a participating center for blood draws and follow-up are eligible.
Not a fit: Patients who do not have sarcoma or whose tumors do not shed measurable ctDNA (for example very small or certain low-shedding subtypes) are unlikely to derive direct benefit from the test.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive tool to help detect and monitor sarcoma, inform treatment decisions, and identify recurrence earlier.
How similar studies have performed: Liquid biopsy and ctDNA methods have shown promise in other cancers and in early sarcoma reports, but sarcoma-specific LP-WGS testing is still emerging and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Written informed consent or assent when applicable from the participant, LAR, parent or legal guardian and HIPAA authorization for release of personal health information.
2. All ages allowed
3. Suspected or confirmed disease (must meet one of the criteria below):
1. Suspected bone or soft tissue tumor concerning for sarcoma (pending confirmation of sarcoma diagnosis)
OR
2. Suspected lipomatous mass concerning for ALT or WDLS with planned surgery
OR
3. Confirmed bone or soft tissue sarcoma meeting one of the criteria below:
* Non-metastatic/Resectable sarcoma with either planned or currently receiving therapy
* Metastatic or unresectable sarcoma, with planned or currently receiving therapy
* Non-metastatic sarcoma under surveillance with no more than 1 year from completion of therapy
Exclusion Criteria:
* none
Where this trial is running
Charlotte, North Carolina and 1 other locations
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Johann Hsu, MD — Wake Forest University Health Sciences
- Study coordinator: Meg Lattanze
- Email: Megan.Lattanze@advocatehealth.org
- Phone: 980-442-4239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.