Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
UNC Lineberger Comprehensive Cancer Center
180 participants
Mar 17, 2023
OBSERVATIONAL
Conditions
Summary
This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy. Recent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.
Eligibility
Inclusion Criteria5
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Subject is willing and able to provide written informed consent to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.
- Age ≥ 18 years at the time of consent.
- Histological, cytological, or radiographic evidence/confirmation of a gastrointestinal malignancy or sarcoma.
- Females with childbearing potential and male subjects with fathering potential are allowed to participate in this study.
Exclusion Criteria2
- Inability or unwillingness to provide informed consent
- Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment
Interventions
Patient Reported Outcome (PRO) questionnaire
Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05743426