Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT03896620
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preoperative RT — DEVICE
    Radiation delivered before surgery.
  • Postoperative RT — DEVICE
    Radiation delivered after surgery.
  • Chemotherapy — DRUG
    Physician's choice of chemotherapy.
  • Surgery — OTHER
    Surgical excision of tumor.

Study Details

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.

Key Dates

Start date
Jun 18, 2019
Status verified
Dec 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Stage II-III Sarcomas undergoing preoperative radiation therapy (RT)
    This group will have preoperative chemotherapy (if administered), preoperative radiation and surgery.
  • Arm: Stage II-III Sarcomas undergoing postoperative RT
    This group will have surgery, postoperative radiation, post operative chemotherapy (if administered).
  • Arm: Stage IV Sarcomas
    This group will only have chemotherapy.

Primary Outcome Measure

ctDNA measure [ Time Frame: Reported at baseline, at 4 weeks after first intervention, 4 weeks following radiation treatment, 4 weeks post third intervention, 1 year. ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    414-805-8900
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Meena Bedi, MD
[email protected]
414-805-4400

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By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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