Prediction of Radiation-induced Late Intestinal Injury

NCT05749510 | Not Yet Recruiting

• 1 other identifier: EC-076
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Radiation-induced late intestinal injury, Rectal cancer, NCRT, TME, Phase separation

Outcome Measures

Primary Outcomes (1)

• AUC

  Area Under Curve of the prediction model in predicting RLII.

  1 year after TME

Secondary Outcomes (1)

• Accuracy, precision, specificity, and sensitivity

  1 year after TME

Study Arms (1)

NCRT+TME

Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision (TME) Interventions

Other: NCRT+TME

Interventions

NCRT+TME OTHER

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

NCRT+TME

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with locally advanced rectal cancer, who undergo NCRT and TME at The Sixth Affiliated Hospital, Sun Yat-sen University will be assessed for suitability for inclusion.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Related Publications (1)

• Fan 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 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yun-Long Wang, Ph.D

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-Long Wang, Ph.D

CONTACT

+862085655907; wangylong7@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share