Clinical trial NCT06958107: LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients
Official title: Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sarcoma
Keywords: circulating tumor DNA
liquid biopsy
bone or soft tissue Sarcoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Paula Takacs Foundation
First posted: 2025-05-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of all ages with concern for or diagnosed with bone or soft tissue sarcoma or lipomatous mass will be identified by treatment investigators in oncology clinics treatment patients with sarcoma

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with ctDNA detected
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Quantity of ctDNA detected
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Johann Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: