Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

NCT03896620 | Recruiting DMC FDA Drug FDA Device

• 1 other identifier: PRO00034441
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Sarcoma

Keywords

Sarcoma; ctDNA

Outcome Measures

Primary Outcomes (1)

• ctDNA measure

  Blood samples will be collected. ctDNA is measured in percentage: variant allele fraction percentage.

  Reported at baseline, at 4 weeks after first intervention, 4 weeks following radiation treatment, 4 weeks post third intervention, 1 year.

Study Arms (3)

Stage II-III Sarcomas undergoing preoperative radiation therapy (RT)

This group will have preoperative chemotherapy (if administered), preoperative radiation and surgery.

Device: Preoperative RT; Drug: Chemotherapy; Other: Surgery

Stage II-III Sarcomas undergoing postoperative RT

This group will have surgery, postoperative radiation, post operative chemotherapy (if administered).

Device: Postoperative RT; Drug: Chemotherapy; Other: Surgery

Stage IV Sarcomas

This group will only have chemotherapy.

Drug: Chemotherapy

Interventions

Preoperative RT DEVICE

Radiation delivered before surgery.

Stage II-III Sarcomas undergoing preoperative radiation therapy (RT)

Postoperative RT DEVICE

Radiation delivered after surgery.

Stage II-III Sarcomas undergoing postoperative RT

Chemotherapy DRUG

Physician's choice of chemotherapy.

Stage II-III Sarcomas undergoing postoperative RT; Stage II-III Sarcomas undergoing preoperative radiation therapy (RT); Stage IV Sarcomas

Surgery OTHER

Surgical excision of tumor.

Stage II-III Sarcomas undergoing postoperative RT; Stage II-III Sarcomas undergoing preoperative radiation therapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation.
• 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.

You may not qualify if:

• Pregnant women.
• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In this project, the investigator will do genetic testing on blood and tumor samples. Whole genome sequencing will be included as part of the genetic testing for this research. Genetic testing will be done because the study doctor would like to identify new biomarkers of sarcoma.

MeSH Terms

Conditions

Sarcoma

Interventions

Postoperative Period; Drug Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Perioperative Period; Patient Care; Health Services; Health Care Facilities Workforce and Services; Therapeutics

Study Officials

• Meena Bedi

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

414-805-8900; cccto@mcw.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: June 18, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)