Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-80 years;
Diagnosed with chronic radiation enteropathy.
Disqualifiers
Ongoing cancer therapy;
Tumor recurrence or metastasis.
Trial population
The study population will consist of prospectively recruited adult patients clinically diagnosed with chronic radiation enteropathy at the Sixth Affiliated Hospital of Sun Yat-sen University. The inclusion criteria are: age between 18 and 80 years, and a clinical confirmation of chronic radiation enteropathy. Patients who are currently undergoing cancer therapy or who have experienced tumor recurrence or metastasis are excluded. This study will be conducted in accordance with the Declaration of Helsinki and has been approved by the hospital's Ethics Committee. Written informed consent will be obtained from all participants prior to their enrollment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Chronic radiation enteropathy
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov