Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:

Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03896620
• Other study ID #: PRO00034441
• Status: Recruiting
• Start date: June 18, 2019
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2023
• Source: Medical College of Wisconsin
• Contact: Medical College of Wisconsin Cancer Center Clinical Trials Offic
• Phone: 414-805-8900
• Email: cccto[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Sarcoma

Intervention

Device:
• Preoperative RT
Radiation delivered before surgery.
• Postoperative RT
Radiation delivered after surgery.

Drug:
• Chemotherapy
Physician's choice of chemotherapy.

Other:
• Surgery
Surgical excision of tumor.

Locations

Country	Name	City	State
United States	Froedtert Hospital & the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Overall survival.	This is defined as the number of months from study entry to death from any cause.	2 Years
Secondary	Progression-free survival.	The number of months from study entry to disease progression or death from any cause.	2 Years