Sarcoma
Conditions
Keywords
circulating tumor DNA, liquid biopsy, bone or soft tissue 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.
Interventions
OTHERNon-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
OTHERMetastatic and Un-resectable
Blood Draw Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months
OTHERNo 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
OTHERALT or WDLS
Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery)
Sponsors
Wake Forest University Health Sciences
Paula Takacs Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with ctDNA detected | Approximately 24 months | A binary variable indicating whether or not ctDNA was detected by low pass whole genome sequencing (LP-WGS) in the sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of ctDNA detected | Approximately 24 months | 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) |
Countries
United States
Contacts
CONTACTMeg Lattanze
PRINCIPAL_INVESTIGATORJohann Hsu, MD
Wake Forest University Health Sciences
Outcome results
None listed