Monitoring disease outcomes and side effects in patients with gastrointestinal cancers and sarcomas
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
This study is trying to see how standard treatments for gastrointestinal cancers and sarcomas affect patients' health and side effects over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05743426 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess disease outcomes and toxicities in patients with gastrointestinal malignancies and sarcomas receiving standard treatments, including radiotherapy. By utilizing standardized assessments, the study will prospectively monitor how recent advancements in treatment approaches impact patient outcomes and side effects. The findings will help refine current treatment strategies and inform future clinical trial designs.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed gastrointestinal malignancies or sarcomas who can provide informed consent.
Not a fit: Patients unable or unwilling to provide informed consent or those who cannot commit to follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of treatment effects, leading to improved management of gastrointestinal cancers and sarcomas.
How similar studies have performed: While similar observational studies have been conducted, this specific approach focusing on recent treatment advancements is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below. 1. 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. 2. Age ≥ 18 years at the time of consent. 3. Histological, cytological, or radiographic evidence/confirmation of a gastrointestinal malignancy or sarcoma. 4. Females with childbearing potential and male subjects with fathering potential are allowed to participate in this study. Exclusion Criteria All subjects meeting any exclusion criteria at baseline will be excluded from study participation. 1. Inability or unwillingness to provide informed consent 2. Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Theodore K Yanagihara — Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
- Study coordinator: Victoria Xu, MD, PhD
- Email: victoria_xu@med.unc.edu
- Phone: +1 984-974-8744
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.