Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
Data Collection
Neoplasms+1
+ Neoplasms by Histologic Type
+ Sarcoma
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: June 18, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, United StatesOpen Froedtert Hospital & the Medical College of Wisconsin in Google Maps