Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy (NCT07759258) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy
50 participantsStarted 2026-08-28
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Plasma GLP-2 Concentration Over Time
Timeframe: Baseline (before initiation of radiotherapy), within 24 hours after completion of the final radiotherapy session, and 1 month after completion of radiotherapy
. 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.