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

Not yet recruiting

• Conditions: Sarcoma

• Registration Number: NCT06958107
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-27
• Study First Submitted QC: 2025-04-27
• Last Update Submitted: 2025-04-27
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Study Start: 2025-06
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with ctDNA detected	Approximately 24 months	A binary variable indicating whether or not ctDNA was detected by low pass whole genome sequencing (LP-WGS) in the sample.

Secondary Outcome Measures

Name	Time	Method
Quantity of ctDNA detected	Approximately 24 months	A longitudinal continuous variable indicating the quantitative levels of ctDNA in the sample as measured by LP-WGS. Timepoints include pre-treatment, at disease evaluations during treatment, post-treatment, at remission/complete response (if applicable), during surveillance (if applicable), and at recurrence/progression (if applicable)

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States