Radiation Enteritis, Radiation Proctitis, Radiotherapy
Conditions
Keywords
radiotherapy, radiation proctitis, radiation enteritis
Brief summary
This is a prospective, observational study aimed at exploring the associations between the clinical classification of chronic radiation enteropathy 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 chronic radiation enteropathy, and provide scientific support for improving the prognosis of similar patients.
Interventions
None listed
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years; 2. Diagnosed with chronic radiation enteropathy.
Exclusion criteria
1. Ongoing cancer therapy; 2. Tumor recurrence or metastasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between Clinical Classification and Clinical Outcomes | 6 months | To investigate the association between clinical classification and outcomes, the primary outcome was assessed as complete remission of their primary symptom, while the measure was identified as the remission rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Accuracy of Endoscopic Characteristics for Clinical Classification | 6 months | Using prospectively collected endoscopic data, the investigators will assess the association between specific endoscopic features and the data-driven clinical classification. The predictive accuracy will be quantitatively measured using metrics including sensitivity and specificity. The results aim to determine whether endoscopic findings can serve as reliable indicators for subtype identification. |
| Predictive Accuracy of Imaging Evaluation for Clinical Classification | 6 months | Using prospectively collected endoscopic data, the investigators will assess the association between features of MRI/CT and the data-driven clinical classification. The predictive accuracy will be quantitatively measured using metrics including sensitivity and specificity. The results aim to determine whether endoscopic findings can serve as reliable indicators for subtype identification. |
Countries
China
Contacts
CONTACTQiyuan Qin, M.D.
Outcome results
None listed