Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury

Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury: A Prospective, Observational Study

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 Overview

• Status: Recruiting
• Conditions: Radiotherapy; Radiation Proctitis

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Qiyuan Qin, M.D.; Phone Number: 86-13580359171; Email: qinqy3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Qiyuan Qin, M.D.; Phone Number: 86-20-38254052; Email: qinqy3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of prospectively recruited adult patients clinically diagnosed with radiation rectal injury. Participants will be selected from the patient cohort 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 radiation rectal injury. 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.

Description

Inclusion Criteria:

1. 18-80 years;
2. Diagnosed with radiation rectal injury.

Exclusion Criteria:

1. Ongoing cancer therapy;
2. Tumor recurrence or metastasis.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic radiation proctitis; Patients diagnosed with chronic radiation proctitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; radiation proctitis
• Other Study ID Numbers: CRP202501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No