Dynamic Changes in Plasma GLP-2 and Their Association With Acute Radiation Enteritis in Patients Undergoing Abdominopelvic Radiotherapy: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Change in Plasma GLP-2 Concentration Over Time
研究概览
简要总结
This prospective observational study will enroll 50 adults who are scheduled to receive radiotherapy to the abdomen or pelvis. The study will not assign any additional treatment or change routine clinical care. Residual blood samples from routine clinical testing will be collected before radiotherapy, at the end of radiotherapy, and one month after radiotherapy to measure plasma glucagon-like peptide-2 (GLP-2).
Participants will be followed for gastrointestinal symptoms and the occurrence and severity of acute radiation enteritis. Researchers will compare GLP-2 levels and changes between participants who develop acute radiation enteritis and those who do not. The study will also examine the associations of GLP-2 with markers of intestinal barrier injury and inflammation, radiotherapy dose parameters, nutritional status, and quality of life. The aim is to explore whether plasma GLP-2 may help assess the risk and severity of acute radiation enteritis.
详细描述
This is a single-center, prospective observational cohort study involving approximately 50 adults receiving abdominopelvic radiotherapy. Participants will receive radiotherapy and other supportive treatment according to routine clinical practice. The study will not alter the participants' prescribed treatment or assign any study-specific therapeutic intervention.
Residual blood samples from routine clinical testing will be collected at three time points: before radiotherapy, at the completion of radiotherapy, and one month after radiotherapy. The primary outcome is the plasma glucagon-like peptide-2 (GLP-2) level and its change over time. Additional assessments will include diamine oxidase, D-lactate, interleukin-6, tumor necrosis factor-alpha, and interleukin-1 beta. Citrulline, intestinal fatty acid-binding protein, and metabolomic analyses may also be performed when feasible.
Clinical information will include demographic characteristics, cancer and treatment characteristics, gastrointestinal symptoms, radiotherapy dose parameters, nutritional status, laboratory findings, and quality-of-life assessments. After follow-up, participants will be classified according to whether acute radiation enteritis occurred. GLP-2 levels and longitudinal changes will be compared between participants with and without acute radiation enteritis. Associations between GLP-2 and intestinal injury markers, inflammatory factors, symptom severity, radiotherapy dose parameters, nutritional status, and quality of life will also be evaluated.
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
- •Inclusion Criteria:
- •Age 18 to 75 years.
- •Diagnosed with a malignancy and scheduled to receive abdominopelvic radiotherapy.
- •No active enteritis or moderate-to-severe diarrhea before radiotherapy.
- •Expected to complete the planned course of radiotherapy and the 1-month post-radiotherapy follow-up.
- •Able to complete clinical data collection, gastrointestinal symptom assessment, nutritional assessment, quality-of-life assessment, and collection of residual peripheral venous blood samples from routine clinical testing.
- •Willing to participate and able to provide written informed consent.
排除标准
- •Moderate-to-severe diarrhea, active inflammatory bowel disease, intestinal obstruction, short bowel syndrome, or severe malabsorption before radiotherapy.
- •Previous radiotherapy to the same abdominopelvic region.
- •Severe cardiac, hepatic, or renal failure.
- •Active infection, severe systemic inflammatory response, or active autoimmune disease.
- •Receipt during the study of treatments considered by the investigator to substantially affect intestinal hormones, inflammatory markers, or intestinal barrier function and interfere with the study results.
- •Pregnancy or breastfeeding.
- •Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.
结局指标
主要结局
Change in Plasma GLP-2 Concentration Over Time
时间窗: Baseline (before initiation of radiotherapy), within 24 hours after completion of the final radiotherapy session, and 1 month after completion of radiotherapy
Plasma glucagon-like peptide-2 (GLP-2) concentration will be measured using an enzyme-linked immunosorbent assay or another validated quantitative method. Absolute GLP-2 concentrations and changes from the pre-radiotherapy level will be compared between participants who develop acute radiation enteritis and those who do not.
次要结局
未报告次要终点
研究者
Wang Xinying
Professor
Jinling Hospital, China