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).
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
Enrollment
300
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
Blood Draw Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months
Levine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGAtrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
RECRUITINGNumber 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.
Time frame: Approximately 24 months
Quantity of ctDNA detected
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)
Time frame: Approximately 24 months
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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
Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery)