NCT05749497 (PCRAII) is a clinical trial of NCRT+TME in Radiation-induced Intestinal Injury, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University.

Who is sponsoring NCT05749497?

NCT05749497 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University.

What drugs are being tested in NCT05749497?

Interventions in NCT05749497: NCRT+TME.

What condition does NCT05749497 study?

NCT05749497 studies Radiation-induced Intestinal Injury.

Is NCT05749497 still recruiting?

NCT05749497 is currently status unknown. Last updated 1 March 2023.

Last reviewed 2023-03-01 · How we verify

NCT05749497: PCRAII

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prediction of the Chronicization of Radiation-induced Acute Intestinal Injury Based on the Expression Level of lncRNA

Status unknown Last updated 1 March 2023

What this trial tests

trial testing NCRT+TME in Radiation-induced Intestinal Injury in 200 participants. Status unknown.

Timeline

1 March 2023

Primary endpoint
31 December 2025

1 March 2026

Quick facts

Lead sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 March 2023
Primary completion	31 December 2025
Estimated completion	1 March 2026

Drugs / interventions tested

NCRT+TME

Conditions studied

Radiation-induced Intestinal Injury — all drugs for Radiation-induced Intestinal Injury →

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Radiation-induced Intestinal Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Our team has constructed a prediction model based on the expression level of lncRNA (lncRNA-UCID、NEAT1、ciRS-7) 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 lncRNA 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 lncRNA is more than 0.8.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Long non-coding RNAs in ferroptosis, pyroptosis and necroptosis: from functions to clinical implications in cancer therapy.
Huang K, Yu L, Lu D, Zhu Z, et al · · 2024 · cited 10× · PMID 39267831 · DOI 10.3389/fonc.2024.1437698

Verify or expand the search:

Other trials of NCRT+TME

Trials testing the same drug.

NCT05749510 — Prediction of Radiation-induced Late Intestinal Injury · unknown
NCT05749484 — Prediction of the Chronicization of Radiation-induced Acute Intestinal Injury · unknown

Other Sixth Affiliated Hospital, Sun Yat-sen University trials

Trials by the same sponsor.

NCT07538284 — MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) · Phase 2, PHASE3 · not yet recruiting
NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05749497 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
Last refreshed: 1 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05749497.

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