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Prediction of Radiation-induced Late Intestinal Injury

NCT05749510 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-03-01

No results posted yet for this study

Summary

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

  • Radiation-induced Intestinal Injury

Interventions

OTHER

NCRT+TME

The eligible patients who voluntarily sign the consent form will undergo NCRT and TME according to treatment guidelines.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun-Long Wang, Ph.D · The Sixth Affiliated Hospital, Sun Yat-sen University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-12-31
Completion
2026-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05749510 on ClinicalTrials.gov