Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury

NCT07378631 | Recruiting

• 1 other identifier: CRP202501
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiotherapy; Radiation Proctitis

Keywords

radiotherapy; radiation proctitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Predictive Accuracy of Endoscopic Characteristics for Clinical Subtyping

  6 months

• Predictive Accuracy of Imaging Evaluation for Clinical Subtyping

  6 months

Study Arms (1)

Chronic radiation proctitis

Patients diagnosed with chronic radiation proctitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years;
• Diagnosed with radiation rectal injury.

You may not qualify if:

• Ongoing cancer therapy;
• Tumor recurrence or metastasis.

Sponsors & Collaborators

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

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Qiyuan Qin, M.D.

CONTACT

86-13580359171; qinqy3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 30, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (1)