Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury: A Prospective, Observational Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Association between Clinical Classification and Clinical Outcomes
Overview
Brief Summary
This is a prospective, observational study aimed at exploring the associations between the clinical subtypes of radiation rectal injury and prognosis. The study is planed to commence in November 2025 and prospectively observe 150 patients. During the study period, researchers will not intervene in clinical treatment decisions but will only collect patient clinical information, intestinal endoscopy/imaging/pathological data, test results, and follow-up data. The study results will fill the evidence gap in this field, advance the diagnosis and treatment of radiation-induced rectal injury, and provide scientific support for improving the prognosis of similar patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-80 years;
- •Diagnosed with radiation rectal injury.
Exclusion Criteria
- •Ongoing cancer therapy;
- •Tumor recurrence or metastasis.
Arms & Interventions
Chronic radiation proctitis
Patients diagnosed with chronic radiation proctitis
Outcomes
Primary Outcomes
Association between Clinical Classification and Clinical Outcomes
Time Frame: 6 months
To investigate the association between clinical subtypes and outcomes, the primary outcome was assessed as complete remission of their primary symptom, while the measure was identified as the remission rate.
Secondary Outcomes
- Predictive Accuracy of Endoscopic Characteristics for Clinical Subtyping(6 months)
- Predictive Accuracy of Imaging Evaluation for Clinical Subtyping(6 months)