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Trial Title:
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
NCT ID:
NCT05743426
Condition:
Sarcoma
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Conditions: Keywords:
toxicity
survey
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Survey
Description:
Patient Reported Outcome (PRO) questionnaire
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
Toxicity Assessments
Description:
Toxicity Assessments will be performed using the National Cancer Institute Common
Terminology Criteria (NCI-CTCAE).
Arm group label:
Single Arm
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.
Criteria for eligibility:
Study pop:
Subjects with gastrointestinal malignancy or sarcoma receiving treatment at study center.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victoria Xu
Phone:
984-974-8744
Email:
victoria_xu@med.unc.edu
Investigator:
Last name:
Theodore K Yanagihara, MD
Email:
Principal Investigator
Start date:
March 17, 2023
Completion date:
January 1, 2036
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05743426
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
