Prediction of Radiation-induced Acute Intestinal Injury Based on the Phase Separation Level of DNA Repair Factors: a Prospective, Observational and Confirmatory Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- AUC
研究概览
简要总结
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.
详细描述
Study design and setting The study is a prospective, observational, confirmatory, single-center study in predicting radiation-induced late intestinal injury based on the phase separation level of DNA repair factors.
Participants 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.
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.
Interventions The eligible patients who voluntarily sign the consent form will undergo NCRT and TME according to treatment guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent. 18-75 years of age. ECOG score for performance status is 0-
- •Locally advanced rectal adenocarcinoma (T3-4/N+M0) with pathological and MRI diagnosis. Patient will undergo NCRT and TME therapies.
排除标准
- •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.
结局指标
主要结局
AUC
时间窗: 1 year after TME
Area Under Curve of the prediction model in predicting RLII.
次要结局
- Accuracy, precision, specificity, and sensitivity(1 year after TME)