How types of radiation-caused rectal injury relate to recovery and outcomes
Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury: A Prospective, Observational Study
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07378631 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-80 years; 2. Diagnosed with radiation rectal injury. Exclusion Criteria: 1. Ongoing cancer therapy; 2. Tumor recurrence or metastasis.
Where this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.