Identifying tumor DNA in blood for soft tissue sarcoma diagnosis
Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
Medical College of Wisconsin · NCT03896620
This study is testing if analyzing tumor DNA in the blood can help doctors diagnose and monitor soft tissue sarcoma more easily and accurately without needing to do invasive biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT03896620 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood samples from patients diagnosed with localized and metastatic soft tissue sarcomas alongside tumor biopsies. The goal is to analyze circulating tumor DNA (ctDNA) in the blood to identify potential biomarkers that could improve the diagnosis and monitoring of sarcoma without the need for invasive tissue biopsies. By measuring ctDNA levels at various time points during treatment, the study seeks to correlate these changes with patient outcomes such as overall survival and progression-free survival.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of soft tissue sarcoma who are scheduled for a biopsy.
Not a fit: Patients with prior therapy to the primary site of sarcoma or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive diagnostic methods for sarcoma, improving patient comfort and safety.
How similar studies have performed: While the use of ctDNA in other cancers has shown promise, this specific approach in soft tissue sarcoma is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milwaukee, Wisconsin
- Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Meena Bedi — Medical College of Wisconsin
- Study coordinator: Medical College of Wisconsin Cancer Center Clinical Trials Office
- Email: cccto@mcw.edu
- Phone: 414-805-8900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.