How types of radiation-caused rectal injury relate to recovery and outcomes
Official title: Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy: A Prospective, Observational Study
Run by Sixth Affiliated Hospital, Sun Yat-sen University · NCT07378631 · Data updated 2026-11-12
This project will try to see if different clinical types of radiation-caused rectal injury predict recovery and long-term outcomes in adults aged 18–80.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 4, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07378631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 diagnosed with radiation rectal injury who are not receiving active cancer therapy and have no tumor recurrence or metastasis.
✕Probably not a fit
Patients currently undergoing cancer therapy, those with tumor recurrence or metastasis, or people outside the 18–80 age range are unlikely to receive direct benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort planned to enroll 150 adults with radiation-induced rectal injury beginning in November 2025 at the Sixth Affiliated Hospital, Sun Yat-sen University in Guangzhou. Researchers will not change clinical care but will collect clinical data, endoscopy, imaging, pathology results, laboratory tests, and follow-up information. Clinical subtypes of rectal injury will be classified and correlated with short- and long-term prognosis using this prospectively gathered dataset. The goal is to fill current evidence gaps and provide data to improve diagnosis, monitoring, and management strategies for affected patients.
Why it matters
Potential benefit: If successful, the results could help clinicians predict which patients face higher risk of poor outcomes and tailor follow-up and treatment accordingly.
How similar studies have gone: Most prior work has been retrospective or small case series, so prospective data linking clinical subtypes to prognosis are limited and this approach is relatively novel for the condition.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-80 years; 2. Diagnosed with chronic radiation enteropathy. Exclusion Criteria: 1. Ongoing cancer therapy; 2. Tumor recurrence or metastasis.
Where it's running
-
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Qiyuan Qin, M.D.
- Email: qinqy3@mail.sysu.edu.cn
- Phone: 86-13580359171
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.