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

Overview

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.

Interventions

• Other Non-Metastatic and Resectable
  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
• Other Metastatic and Un-resectable
  Blood Draw Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months
• Other No evidence of disease, under surveillance
  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
• Other ALT or WDLS
  Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery)

Primary outcome measures

• Number of participants with ctDNA detected [Time frame: Approximately 24 months]

Secondary outcome measures (1)

• Quantity of ctDNA detected [Time frame: Approximately 24 months]

Eligibility criteria

Inclusion criteria

• 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)

OR

• Suspected lipomatous mass concerning for ALT or WDLS with planned surgery

OR

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• Levine Cancer Institute — Charlotte
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Identifiers

NCT: NCT06958107 · IRB00127078 · LCI-SAR-BSTS-CTDNA-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗