LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

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).

In this ever-expanding age of precision oncology, the stagnant treatment algorithms and subsequent oncologic outcomes for sarcoma patients highlight the need for novel technologies to help clinicians treat these patients. While countless prognostic and therapeutic molecular biomarkers have been identified for many other cancers, sarcoma practitioners have strikingly few tumor markers to guide treatment. The development of a sarcoma-specific liquid biopsy could greatly help clinicians with diagnosis, prognostication, treatment response, minimal recurrent disease, and recurrence. The purpose of this study is to clinically evaluate ctDNA liquid biopsy approaches in adult and pediatric patients with bone and soft tissue sarcomas.

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