Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT03896620
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03896620
Study Brief:
Protocol Section:
NCT03896620