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

NCT06958107 | Recruiting DMC

• 2 other identifiers: IRB00127078LCI-SAR-BSTS-CTDNA-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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).

Conditions

Sarcoma

Keywords

circulating tumor DNA; liquid biopsy; bone or soft tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with ctDNA detected

  A binary variable indicating whether or not ctDNA was detected by low pass whole genome sequencing (LP-WGS) in the sample.

  Approximately 24 months

Secondary Outcomes (1)

• Quantity of ctDNA detected

  Approximately 24 months

Study Arms (4)

Non-Metastatic and Resectable

Cohort A1: Non-metastatic/ Resectable (with planned or you are undergoing therapy)- your cancer has not spread, may be able to remove it with operation

Other: Non-Metastatic and Resectable

Metastatic and Un-resectable

Cohort A2: Metastatic/ Unresectable (with planned or you are undergoing therapy)- your cancer has spread, not able to operate at this time to take out all the cancer

Other: Metastatic and Un-resectable

No evidence of disease, under surveillance

Cohort B: No evidence of disease/ surveillance (you have completed initial therapy)- currently there is no evidence of your cancer/disease and you are under surveillance, meaning your physician is checking your medical situation at intervals or occasionally for any sign of changes

Other: No evidence of disease, under surveillance

ALT or WDLS

Cohort C: You have been diagnosed with ALT (atypical lipoma) or WDLS (well-differentiated liposarcoma)

Other: ALT or WDLS

Interventions

Non-Metastatic and Resectable OTHER

Blood Draw Timepoints: * Before any treatment begins * After Neo-adjuvant therapy (only if you receive this type of therapy) * After local surgery * After Adjuvant therapy (only if you receive this type of therapy) * Follow up after adjuvant therapy: at Months 3, 6, 9, 12, 15, 18, and 24 * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis

Non-Metastatic and Resectable

Metastatic and Un-resectable OTHER

Blood Draw Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months

Metastatic and Un-resectable

No evidence of disease, under surveillance OTHER

Blood Draw Timepoints: * From completion of treatment- at Months 3, 6, 9, 12, 15, 18, and 24; depending on when you enroll into the study you will start at the next timepoint in this schedule * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis

No evidence of disease, under surveillance

ALT or WDLS OTHER

Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery)

ALT or WDLS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Written informed consent or assent when applicable from the participant, LAR, parent or legal guardian and HIPAA authorization for release of personal health information.
• All ages allowed
• Suspected or confirmed disease (must meet one of the criteria below):
• Suspected bone or soft tissue tumor concerning for sarcoma (pending confirmation of sarcoma diagnosis)
• Suspected lipomatous mass concerning for ALT or WDLS with planned surgery
• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Paula Takacs Foundation: collaborator

Study Sites (2)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen

MeSH Terms

Conditions

Sarcoma

Interventions

Alanine Transaminase

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Transaminases; Nitrogenous Group Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Johann Hsu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meg Lattanze

CONTACT

980-442-4239; Megan.Lattanze@advocatehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 6, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (2)