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NCT06958107 | RECRUITING | Sarcoma

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

Condition or disease

Sarcoma

Intervention/treatment

Non-Metastatic and Resectable

Metastatic and Un-resectable

No evidence of disease, under surveillance

ALT or WDLS

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 Type : OBSERVATIONAL
Estimated Enrollment : 300 participants
Official Title : Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients
Actual Study Start Date : 2025-08-21
Estimated Primary Completion Date : 2030-01
Estimated Study Completion Date : 2030-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Location Details

NCT06958107

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, North Carolina

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27103