Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy

NCT07759258 | Not Yet Recruiting

• 1 other identifier: 2026DZKY-133-01
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Radiation Enteritis

Keywords

Acute Radiation Enteritis; Glucagon-Like Peptide-2; Abdominopelvic Radiotherapy; Intestinal Barrier Injury

Outcome Measures

Primary Outcomes (1)

• Change in Plasma GLP-2 Concentration Over Time

  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.

  Baseline (before initiation of radiotherapy), within 24 hours after completion of the final radiotherapy session, and 1 month after completion of radiotherapy

Interventions

Abdominopelvic Radiotherapy RADIATION

Participants will receive abdominopelvic radiotherapy according to routine clinical care. The study will not assign or modify the radiotherapy regimen. Radiotherapy-related information, including the treatment site, total dose, dose per fraction, number of fractions, treatment field, and dose parameters for organs at risk, will be recorded.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of approximately 50 adults aged 18 to 75 years with malignant tumors who are scheduled to receive abdominopelvic radiotherapy at a single medical center. Eligible participants will be enrolled prospectively before radiotherapy and followed throughout radiotherapy until 1 month after treatment completion. Participants will receive routine clinical care without any study-assigned therapeutic intervention. Residual blood samples from routine clinical testing and relevant clinical, symptom, nutritional, radiotherapy, and quality-of-life data will be collected.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wang Xinying: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08