Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Radiotherapy, Radiation Proctitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury: A Prospective, Observational Study
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.
Primary outcome measures
- Association between Clinical Classification and Clinical Outcomes [Time frame: 6 months]
Secondary outcome measures (2)
- Predictive Accuracy of Endoscopic Characteristics for Clinical Subtyping [Time frame: 6 months]
- Predictive Accuracy of Imaging Evaluation for Clinical Subtyping [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 18-80 years;
- Diagnosed with radiation rectal injury.
Exclusion criteria
- Ongoing cancer therapy;
- Tumor recurrence or metastasis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07378631 · CRP202501