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LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy and Spectroscopy-based Molecular Urinalysis in Sarcoma Patients

Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy and Spectroscopy-based Molecular Urinalysis in Patients With Sarcoma

Who can join

All ages · All sexes

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

About the study

The purpose of this research study is to see how well Low Pass Whole Genome Sequencing (LP-WGS) can detect circulating tumor deoxyribonucleic acid (ctDNA) in the blood of participants who have bone or soft tissue sarcoma (type of cancer). This study is also looking at a new technology called Rametrix® Molecular urinalysis (RMU). The study is using this technology to evaluate changes in the urine that may indicate the presence of disease or cancer.

What is being tested

• Non-Metastatic and Resectable (other)
• Metastatic and Un-resectable (other)
• No evidence of disease, under surveillance (other)
• ALT or WDLS (other)

Sponsor: Wake Forest University Health Sciences · Participants: 300 · Started: Aug 21, 2025

Contact the study team

• Meg Lattanze · Phone: 980-442-4239

Official record on ClinicalTrials.gov — NCT06958107

Locations in the U.S.

Conditions

• Soft Tissue Sarcoma

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.