Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
NCT ID: NCT03896620
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2019-06-18
2026-06-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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Stage II-III Sarcomas undergoing preoperative radiation therapy (RT)
This group will have preoperative chemotherapy (if administered), preoperative radiation and surgery.
Preoperative RT
Radiation delivered before surgery.
Chemotherapy
Physician's choice of chemotherapy.
Surgery
Surgical excision of tumor.
Stage II-III Sarcomas undergoing postoperative RT
This group will have surgery, postoperative radiation, post operative chemotherapy (if administered).
Postoperative RT
Radiation delivered after surgery.
Chemotherapy
Physician's choice of chemotherapy.
Surgery
Surgical excision of tumor.
Stage IV Sarcomas
This group will only have chemotherapy.
Chemotherapy
Physician's choice of chemotherapy.
Interventions
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Preoperative RT
Radiation delivered before surgery.
Postoperative RT
Radiation delivered after surgery.
Chemotherapy
Physician's choice of chemotherapy.
Surgery
Surgical excision of tumor.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of soft tissue sarcoma.
* ≥ 18 years of age.
* Planned biopsy obtained within four weeks after registration.
* History and physical within eight weeks prior to registration.
* For stage II-III patients, no prior therapy to primary site of sarcoma.
* Computerized tomography (CT), positron emission tomography (PET) /CT or MR imaging of the affected primary site obtained in stage II-III or metastatic site in stage IV patients within eight weeks prior to registration.
* CT chest or PET /CT acquired to assess distant disease within eight weeks prior to registration for stage II-III patients.
* Karnofsky Performance Scale (KPS) 60 or above within four weeks prior to registration.
* Documentation of stage within eight weeks prior to registration.
* Biopsy of primary or metastatic disease site must be safe, feasible and in concordance with standard of care per the treating physician and/or radiologist.
* Life expectancy ≥ 12 weeks.
Exclusion Criteria
* Patients with a history of metastatic disease from a primary other than sarcoma.
* Patients who cannot undergo imaging as part of treatment planning or surveillance.
18 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Ciani M Ellison, MD
Assistant Professor
Principal Investigators
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Meena Bedi
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Medical College of Wisconsin Cancer Center Clinical Trials Office
Role: CONTACT
Phone: 414-805-8900
Email: [email protected]
Facility Contacts
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Meena Bedi, MD
Role: primary
Other Identifiers
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PRO00034441
Identifier Type: -
Identifier Source: org_study_id