Clinical trial · Observational
Prediction of Radiation-induced Late Intestinal Injury
Prediction of Radiation-induced Acute Intestinal Injury Based on the Phase Separation Level of DNA Repair Factors: a Prospective, Observational and Confirmatory Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Our team has constructed a prediction model based on the phase separation level of DNA repair factors (MRNIP、NONO、NOP53) to predict radiation-induced late intestinal injury (RLII) and verified the predictive efficacy of the system in retrospective studies. This clinical study intends to further prospectively verify the accuracy of this prediction model in rectal cancer patients. In this study, we plan to enroll 200 patients diagnosed with locally advanced rectal cancer by pathology and MRI, who undergo neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision (TME). We will follow up the occurrence and progression of radiation-induced intestinal injury within 1 year after TME. Phase separation level of DNA repair factors will be detected in pathological tissue after TME and applied to the prediction model to predict RLII. Based on the clinical diagnosis of RLII, the area under curve (AUC), accuracy, precision, specificity, and sensitivity of this prediction model in predicting RLII will be evaluated. The main outcome hypothesis is that the AUC of RLII predicted by the prediction model based on the phase separation level of DNA repair factors is more than 0.8.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-induced Intestinal Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NCRT+TME | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NCRT+TME
- description
- Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision (TME) Interventions
- interventionNames
- Other: NCRT+TME
Primary outcomes (1)
- measure
- AUC
- timeFrame
- 1 year after TME
- description
- Area Under Curve of the prediction model in predicting RLII.
Secondary outcomes (1)
- measure
- Accuracy, precision, specificity, and sensitivity
- timeFrame
- 1 year after TME
- description
- Accuracy, precision, specificity, and sensitivity of the prediction model in predicting RLII.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. 18-75 years of age. ECOG score for performance status is 0-2. Locally advanced rectal adenocarcinoma (T3-4/N+M0) with pathological and MRI diagnosis. Patient will undergo NCRT and TME therapies. Exclusion Criteria: * Patients with other active malignant tumors. Patients who have received pelvic radiotherapy or immunotherapy. Pathological tissue cannot be obtained after TME. Patients with toxicity (CTCAE Grade ≥ 2) caused by previous treatment that has not subsided. Pregnant or lactating women.
References
Publications (1)
- BACKGROUNDFan J, Lin B, Fan M, Niu T, Gao F, Tan B, Du X. Research progress on the mechanism of radiation enteritis. Front Oncol. 2022 Sep 5;12:888962. doi: 10.3389/fonc.2022.888962. eCollection 2022. PMID 36132154