Actively Recruiting
Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
Led by Medical College of Wisconsin · Updated on 2025-12-24
50
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A tissue biopsy is currently the only clinical test or procedure that is able to confirm the initial diagnosis of soft tissue or metastatic sarcoma and evaluate its progress during treatment. However, tissue biopsy collection can be challenging (depending on the location of the tumor), and this procedure poses physical risks to the patient. A tissue biopsy also needs to be recollected at various time points in order to assess if the patient is responding to treatment. In this project, the investigator would like to collect blood samples in addition to the sample of the tumor that will be collected before treatment is started. The investigator would like to analyze both blood and tumor, in hopes of identifying new biomarkers of sarcoma that can help the study doctors better diagnose sarcoma for patients in the future without needing to collect a piece of their tumor. A biomarker is something found in the blood, other body fluids, or tissues that can be used to measure the progress of disease, how a treatment is working, or its likelihood of being successful. In this project, the investigator would like to compare ctDNA from blood to the DNA in the tumor. ctDNA, or circulating tumor DNA, is DNA originating from the tumor that is present in the blood. It can be assessed by taking an additional sample of blood when it will be collected for normal laboratory tests. These biomarkers may also help the study doctors detect how a patient is responding to their treatment or help predict their response to future treatment.
CONDITIONS
Official Title
Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study-specific evaluation
- Diagnosed with soft tissue sarcoma
- 18 years of age or older
- Planned biopsy obtained within four weeks after registration
- History and physical examination within eight weeks prior to registration
- No prior therapy to primary sarcoma site for stage II-III patients
- CT, PET/CT, or MRI imaging of the affected primary or metastatic site within eight weeks prior to registration
- CT chest or PET/CT to assess distant disease within eight weeks prior to registration for stage II-III patients
- Karnofsky Performance Scale (KPS) score of 60 or above within four weeks prior to registration
- Documentation of cancer stage within eight weeks prior to registration
- Biopsy of primary or metastatic disease site must be safe and feasible per physician or radiologist
- Life expectancy of 12 weeks or more
You will not qualify if you...
- Pregnant women
- History of metastatic disease from a primary cancer other than sarcoma
- Unable to undergo imaging as part of treatment planning or surveillance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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