Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy

Sixth Affiliated Hospital, Sun Yat-sen University150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Radiotherapy Radiation Proctitis Radiation Enteritis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18-80 years; 2. Diagnosed with chronic radiation enteropathy. Exclusion Criteria: 1. Ongoing cancer therapy; 2. Tumor recurrence or metastasis.

Locations (1)

Outcomes

Primary Outcomes

Association between Clinical Classification and Clinical Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Predictive Accuracy of Endoscopic Characteristics for Clinical Classification

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.

Time frame: 6 months

Predictive Accuracy of Imaging Evaluation for Clinical Classification

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.

Time frame: 6 months

Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts