Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury

Sixth Affiliated Hospital, Sun Yat-sen University150 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Radiotherapy Radiation Proctitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Outcomes

Primary Outcomes

Association between Clinical Classification and Clinical Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Predictive Accuracy of Endoscopic Characteristics for Clinical Subtyping

Using prospectively collected endoscopic data, the investigators will assess the association between specific endoscopic features and the data-driven clinical subtypes. 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 Subtyping

Using prospectively collected endoscopic data, the investigators will assess the association between features of MRI/CT and the data-driven clinical subtypes. 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 Subtypes and Prognosis in Radiation Rectal Injury

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts