Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Number of participants with ctDNA detected
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Non-Metastatic and Resectable (Other)
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
Intervention: Metastatic and Un-resectable (Other)
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
Intervention: No evidence of disease, under surveillance (Other)
ALT or WDLS
Cohort C: You have been diagnosed with ALT (atypical lipoma) or WDLS (well-differentiated liposarcoma)
Intervention: ALT or WDLS (Other)
Outcomes
Primary Outcomes
Number of participants with ctDNA detected
Time Frame: 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 Outcomes
- Quantity of ctDNA detected(Approximately 24 months)