Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
NCT ID: NCT05743426
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2023-03-17
2036-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single Arm
Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.
Survey
Patient Reported Outcome (PRO) questionnaire
Toxicity Assessments
Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).
Interventions
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Survey
Patient Reported Outcome (PRO) questionnaire
Toxicity Assessments
Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).
Eligibility Criteria
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Inclusion Criteria
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
2. Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment
18 Years
ALL
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Theodore K Yanagihara
Role: PRINCIPAL_INVESTIGATOR
Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
Locations
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University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2247
Identifier Type: -
Identifier Source: org_study_id
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