An observational study in Sarcoma, sponsored by Medical College of Wisconsin. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Medical College of Wisconsin · Observational
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.
In the proposed study, the investigators wish to prospectively collect blood samples from 25 patients with localized soft tissue sarcomas and 25 patients with metastatic sarcoma (schema III) at various time points outlined. The presence/absence, as well as the change of ctDNA in circulation, will then be measured after the therapies administered and correlated with overall survival, progression-free survival and local control.
The risks to the subjects enrolled on this study include the general risks of undergoing the standard procedures, such as blood draws, imaging, radiation therapy, chemotherapy and surgery, which will be discussed prior to the therapies and images each patient undergoes. The risks of the procedures are not risks of the study with exception to blood draws. There is also a risk of loss of confidentiality, but the data will be deidentified once acquired. Thus, this risk is minimal.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 45 is below the median of 121 across 238 observational studies indexed under Sarcoma.
Browse Sarcoma studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with localized, stage II-III or stage IV histologically confirmed soft tissue sarcomas of the extremity, chest wall or retroperitoneal primaries will be eligible for this study. Stage IV patients may have had prior therapy but must obtain a biopsy within registration requirements for study enrollment.
Exclusion Criteria:
This group will have preoperative chemotherapy (if administered), preoperative radiation and surgery.
Device: Preoperative RT · Drug: Chemotherapy · Other: Surgery
This group will have surgery, postoperative radiation, post operative chemotherapy (if administered).
Device: Postoperative RT · Drug: Chemotherapy · Other: Surgery
This group will only have chemotherapy.
Drug: Chemotherapy
Radiation delivered before surgery.
Radiation delivered after surgery.
Physician's choice of chemotherapy.
Surgical excision of tumor.
ctDNA measure
Blood samples will be collected. ctDNA is measured in percentage: variant allele fraction percentage.
Time frame: Reported at baseline, at 4 weeks after first intervention, 4 weeks following radiation treatment, 4 weeks post third intervention, 1 year.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin