Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

Launched by MEDICAL COLLEGE OF WISCONSIN · Mar 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose and monitor soft tissue sarcoma, a type of cancer that arises in the connective tissues of the body. Currently, doctors typically confirm a sarcoma diagnosis through a procedure called a tissue biopsy, where a small piece of the tumor is taken for testing. However, this can be difficult and carries risks for the patient. In this trial, researchers are looking to collect blood samples along with the tumor sample before treatment starts. They will analyze the blood for something called circulating tumor DNA (ctDNA), which is DNA from the tumor that can be found in the bloodstream. The hope is that by understanding ctDNA, doctors can better diagnose sarcoma and track how well a patient is responding to treatment without needing to perform multiple biopsies.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with soft tissue sarcoma. They should also be planning to have a tissue biopsy within four weeks of joining the study. Other requirements include having certain imaging tests done recently to assess the cancer's stage and ensuring that the biopsy can be safely performed. If a patient joins, they can expect to provide blood samples during their regular lab tests, and their progress will be closely monitored throughout the study. This research could lead to less invasive and more efficient ways to manage sarcoma in the future.

Gender

ALL

Eligibility 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.