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Prediction of the Chronicization of Radiation-induced Acute Intestinal Injury

NCT05749484 · 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 expression level of immune factors (PD-L1, PD-1, CTLA4, Siglec15) to predict the chronicization of radiation-induced acute intestinal injury (RAII) 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) and develop RAII during NCRT or within 1 month. We will follow up the occurrence and progression of radiation-induced intestinal injury within 1 year after TME. Expression levels of immune factors will be detected in pathological tissue after TME and applied to the prediction model to predict the chronicization of RAII. Based on the clinical diagnosis of chronic radiation-induced intestinal injury, the area under curve (AUC), accuracy, precision, specificity, and sensitivity of this prediction model in predicting the chronicization of RAII will be evaluated. The main outcome hypothesis is that the AUC of chronicization of RAII predicted by the prediction model based on the expression level of immune 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 NCT05749484 on ClinicalTrials.gov