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Not yet recruitingNCT07759258Updated Aug 12, 2026

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

An observational study in Radiation Enteritis, sponsored by Wang Xinying. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Wang Xinying · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Radiation Enteritis

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Keywords

  • Acute Radiation Enteritis
  • Glucagon-Like Peptide-2
  • Abdominopelvic Radiotherapy
  • Intestinal Barrier Injury
03

In context

Enteritis

34 studies on the registry are indexed under Enteritis; 7 are open to participants now.

Browse Enteritis studies →

Lead sponsor

Wang Xinying is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria:

  1. Age 18 to 75 years.
  2. Diagnosed with a and scheduled to receive abdominopelvic radiotherapy.
  3. No active enteritis or moderate-to-severe diarrhea before radiotherapy.
  4. Expected to complete the planned course of radiotherapy and the 1-month post-radiotherapy follow-up.
  5. 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.
  6. Willing to participate and able to provide written .

Exclusion Criteria:

  1. Moderate-to-severe diarrhea, active inflammatory bowel disease, intestinal obstruction, short bowel syndrome, or severe malabsorption before radiotherapy.
  2. Previous radiotherapy to the same abdominopelvic region.
  3. Severe cardiac, hepatic, or renal failure.
  4. Active infection, severe systemic inflammatory response, or active disease.
  5. 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.
  6. Pregnancy or breastfeeding.
  7. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Interventions

  • RadiationAbdominopelvic Radiotherapy

    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.

06

What researchers measure

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.

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07759258
Lead sponsor
Wang Xinying
Responsible party
Wang Xinying (Professor, Jinling Hospital, China) — Sponsor-investigator
First posted
Aug 12, 2026
Start date
Aug 28, 2026 (estimated)
Primary completion
Oct 28, 2027 (estimated)
Completion
Oct 28, 2027 (estimated)
Last update
Aug 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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