Radiation EnteritisNCT07759258
Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy
An observational study of Radiation Enteritis, run by Wang Xinying.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation Enteritis
- What is being tested?
- Abdominopelvic Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2026to 28 Oct 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Dynamic Changes in Plasma GLP-2 and Their Association With Acute Radiation Enteritis in Patients Undergoing Abdominopelvic Radiotherapy: A Prospective Observational Study
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.
- Conditions
- Radiation Enteritis
- Being tested
- Abdominopelvic Radiotherapy
- Keywords
- Acute Radiation Enteritis, Glucagon-Like Peptide-2, Abdominopelvic Radiotherapy, Intestinal Barrier Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominopelvic RadiotherapyRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before initiation of radiotherapy), within 24 hours after completion of the final radiotherapy session, and 1 month after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start28 Aug 2026 (estimated)
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EnteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Wang Xinying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Xinying, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759258
- Sponsor's protocol ID
- 2026DZKY-133-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Plasma GLP-2 and Their Association With Acute Radiation Enteritis in Patients Undergoing Abdominopelvic Radiotherapy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07759258
- Acronym / sponsor ID
- 2026DZKY-133-01
- Conditions
- Radiation Enteritis
- Keywords
- Acute Radiation Enteritis, Glucagon-Like Peptide-2, Abdominopelvic Radiotherapy, Intestinal Barrier Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wang XinyingUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominopelvic RadiotherapyParticipants 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. | Radiation | – |
Primary outcome
Change in Plasma GLP-2 Concentration Over Time
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Enteritis, run by Wang Xinying.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma GLP-2 Concentration Over Time (time frame: Baseline (before initiation of radiotherapy), within 24 hours after completion of the final radiotherapy session, and 1 month after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.