RadiotherapyNCT07378631
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
An observational study of Radiotherapy and Radiation Proctitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, observational study aimed at exploring the associations between the clinical classification of chronic radiation enteropathy and prognosis. The study is planed to commence in November 2025 and prospectively observe 150 patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiotherapy, Radiation Proctitis, Radiation Enteritis
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2025to 31 Dec 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of prospectively recruited adult patients clinically diagnosed with chronic radiation enteropathy at the Sixth Affiliated Hospital of Sun Yat-sen University. The inclusion criteria are: age between 18 and 80 years, and a clinical confirmation of chronic radiation enteropathy. Patients who are currently undergoing cancer therapy or who have experienced tumor recurrence or metastasis are excluded. This study will be conducted in accordance with the Declaration of Helsinki and has been approved by the hospital's Ethics Committee. Written informed consent will be obtained from all participants prior to their enrollment.
Who may be able to join
- 18-80 years;
- Diagnosed with chronic radiation enteropathy.
Who cannot join
- Ongoing cancer therapy;
- Tumor recurrence or metastasis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Qiyuan Qin, M.D., 86-20-38254052, qinqy3@mail.sysu.edu.cn
About this study
Official title: Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy: A Prospective, Observational Study
This is a prospective, observational study aimed at exploring the associations between the clinical classification of chronic radiation enteropathy and prognosis. The study is planed to commence in November 2025 and prospectively observe 150 patients. During the study period, researchers will not intervene in clinical treatment decisions but will only collect patient clinical information, intestinal endoscopy/imaging/pathological data, test results, and follow-up data. The study results will fill the evidence gap in this field, advance the diagnosis and treatment of chronic radiation enteropathy, and provide scientific support for improving the prognosis of similar patients.
- Conditions
- Radiotherapy, Radiation Proctitis, Radiation Enteritis
- Keywords
- radiotherapy, radiation proctitis, radiation enteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic radiation enteropathy | Patients diagnosed with chronic radiation enteropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Clinical Classification and Clinical Outcomes
To investigate the association between clinical classification and outcomes, the primary outcome was assessed as complete remission of their primary symptom, while the measure was identified as the remission rate.
Measured: 6 months
Secondary outcomes (2)
Predictive Accuracy of Endoscopic Characteristics for Clinical Classification
Using prospectively collected endoscopic data, the investigators will assess the association between specific endoscopic features and the data-driven clinical classification. The predictive accuracy will be quantitatively measured using metrics including sensitivity and specificity. The results aim to determine whether endoscopic findings can serve as reliable indicators for subtype identification.
Measured: 6 months
Predictive Accuracy of Imaging Evaluation for Clinical Classification
Using prospectively collected endoscopic data, the investigators will assess the association between features of MRI/CT and the data-driven clinical classification. The predictive accuracy will be quantitatively measured using metrics including sensitivity and specificity. The results aim to determine whether endoscopic findings can serve as reliable indicators for subtype identification.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start4 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378631
- Sponsor's protocol ID
- CRP202501
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07378631
- Acronym / sponsor ID
- CRP202501
- Conditions
- Radiotherapy, Radiation Proctitis, Radiation Enteritis
- Keywords
- radiotherapy, radiation proctitis, radiation enteritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 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 is a prospective, observational study aimed at exploring the associations between the clinical classification of chronic radiation enteropathy and prognosis. The study is planed to commence in November 2025 and prospectively observe 150 patients. During the study period, researchers will not intervene in clinical treatment decisions but will only collect patient clinical information, intestinal endoscopy/imaging/pathological data, test results, and follow-up data. The study results will fill the evidence gap in this field, advance the diagnosis and treatment of chronic radiation enteropathy, and provide scientific support for improving the prognosis of similar patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic radiation enteropathy | – | –Patients diagnosed with chronic radiation enteropathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of prospectively recruited adult patients clinically diagnosed with chronic radiation enteropathy at the Sixth Affiliated Hospital of Sun Yat-sen University. The inclusion criteria are: age between 18 and 80 years, and a clinical confirmation of chronic radiation enteropathy. Patients who are currently undergoing cancer therapy or who have experienced tumor recurrence or metastasis are excluded. This study will be conducted in accordance with the Declaration of Helsinki and has been approved by the hospital's Ethics Committee. Written informed consent will be obtained from all participants prior to their enrollment.
Key inclusion criteria (2 listed)
- 18-80 years;
- Diagnosed with chronic radiation enteropathy.
Key exclusion criteria (2 listed)
- Ongoing cancer therapy;
- Tumor recurrence or metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between Clinical Classification and Clinical Outcomes
Time frame: 6 months
To investigate the association between clinical classification and outcomes, the primary outcome was assessed as complete remission of their primary symptom, while the measure was identified as the remission rate.
2 secondary outcomes
Predictive Accuracy of Endoscopic Characteristics for Clinical Classification
Time frame: 6 months
Predictive Accuracy of Imaging Evaluation for Clinical Classification
Time frame: 6 months
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 2 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy and Radiation Proctitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Qiyuan Qin, M.D. (86-13580359171, qinqy3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between Clinical Classification and Clinical Outcomes (time frame: 6 months). 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 2 Sep 2026.