RadiomicsNCT06452550
Neurophenotype Predicts CD Disease Progression
An observational study of Radiomics and Multi-omics, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this observational study is aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of Crohn's Disease patients and assess its ability for predicting disease progression, using multiomics data to interpret the model. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiomics, Multi-omics
- What is being tested?
- Logistic regression (LR) prediction models
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study included adult patients aged 18 to 45 with Crohn's disease (CD) who were admitted to the First Affiliated Hospital of Sun Yat-sen University between May 2021 and June 2025.
Who may be able to join
- (a) CD patients aged 18-45 years; (b) the completion of multimodal brain MRI and administration of psychological questionnaires; (c) MR enterography (MRE), ileocolonoscopy, and blood or faecal samples, collection within one week of brain MRI; (d) a follow-up of at least six months for patients without disease progression; and (e) right-handedness.
Who cannot join
- (a) recent use of antibiotics, probiotics, or prebiotics within three months prior to inclusion; (b) history of neurosurgery, cerebrovascular disease, or brain trauma; (c) use of central nervous system drugs or antidepressants within three months prior to inclusion; (d) identification of brain lesions on MR scan; (e) claustrophobia; or (f) presence of metal implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal MRI-based Neurophenotype Reflecting Brain-gut Interactions to Predict Intestinal Disease Progression in Patients With Crohn's Disease
The goal of this observational study is aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of Crohn's Disease patients and assess its ability for predicting disease progression, using multiomics data to interpret the model.
Participants will be followed-up of at least six months for patients without disease progression to assess the relationship between neurophenotype and intestinal outcomes.
Read the detailed description
Brain-gut axis plays a crucial role in the pathogenesis of Crohn's disease (CD); however, CD neurophenotype and its impact on intestinal disease progression remain unclear. We aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of CD patients and assess its ability for predicting disease progression, using multiomics data to interpret the model. This study enrolled CD patients who underwent baseline testing (including neuroimaging, psychological scales, MR enterography, and ileocolonoscopy) and faecal/blood samples collection. The neurophenotypes of patients were characterized using a neuroimaging-based model. The predictive ability of neurophenotype model for disease progression was evaluated using Cox regression analysis. Multiomics data (including faecal microbiome, faecal/blood metabolomics, intestinal permeability, blood-brain-barrier permeability, and blood neurotransmitter levels) were used to elucidate how neurophenotypes reflect brain-gut interactions.
- Conditions
- Radiomics, Multi-omics
- Being tested
- Logistic regression (LR) prediction models
- Keywords
- Abdominal MRI, Magnetic Resonance Imaging, Crohn's disease, Brain/gut interaction
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Logistic regression (LR) prediction modelsDiagnostic test
Logistic regression model was used to establish a model to distinguish different levels of intestinal inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease patients with no-to-mild inflammation | On MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation. Receives: Diagnostic Test: Logistic regression (LR) prediction models | |
| Crohn's disease patients with moderate-to-severe inflammation | On MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation. Receives: Diagnostic Test: Logistic regression (LR) prediction models |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the ROC curve (AUC) to assess the performance of diagnostic model
After baseline brain MRI scanning, patients were followed up.
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 posted11 Jun 2024
- Study start1 May 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiomicsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehua Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xuehua Li, Principal investigator, Sun Yat-sen University First Affiliated Hospital Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452550
- Sponsor's protocol ID
- 82070680
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Disclosure is subject to application
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal MRI-based Neurophenotype Reflecting Brain-gut Interactions to Predict Intestinal Disease Progression in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT06452550
- Acronym / sponsor ID
- 82070680
- Conditions
- Radiomics, Multi-omics
- Keywords
- Abdominal MRI, Magnetic Resonance Imaging, Crohn's disease, Brain/gut interaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 11 Jun 2024 (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.
The goal of this observational study is aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of Crohn's Disease patients and assess its ability for predicting disease progression, using multiomics data to interpret the model.
Participants will be followed-up of at least six months for patients without disease progression to assess the relationship between neurophenotype and intestinal outcomes.
Detailed description
Brain-gut axis plays a crucial role in the pathogenesis of Crohn's disease (CD); however, CD neurophenotype and its impact on intestinal disease progression remain unclear. We aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of CD patients and assess its ability for predicting disease progression, using multiomics data to interpret the model. This study enrolled CD patients who underwent baseline testing (including neuroimaging, psychological scales, MR enterography, and ileocolonoscopy) and faecal/blood samples collection. The neurophenotypes of patients were characterized using a neuroimaging-based model. The predictive ability of neurophenotype model for disease progression was evaluated using Cox regression analysis. Multiomics data (including faecal microbiome, faecal/blood metabolomics, intestinal permeability, blood-brain-barrier permeability, and blood neurotransmitter levels) were used to elucidate how neurophenotypes reflect brain-gut interactions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease patients with no-to-mild inflammation | – | Diagnostic Test: Logistic regression (LR) prediction modelsOn MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation. |
| Crohn's disease patients with moderate-to-severe inflammation | – | Diagnostic Test: Logistic regression (LR) prediction modelsOn MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study included adult patients aged 18 to 45 with Crohn's disease (CD) who were admitted to the First Affiliated Hospital of Sun Yat-sen University between May 2021 and June 2025.
Key inclusion criteria (1 listed)
- (a) CD patients aged 18-45 years; (b) the completion of multimodal brain MRI and administration of psychological questionnaires; (c) MR enterography (MRE), ileocolonoscopy, and blood or faecal samples, collection within one week of brain MRI; (d) a follow-up of at least six months for patients without disease progression; and (e) right-handedness.
Key exclusion criteria (1 listed)
- (a) recent use of antibiotics, probiotics, or prebiotics within three months prior to inclusion; (b) history of neurosurgery, cerebrovascular disease, or brain trauma; (c) use of central nervous system drugs or antidepressants within three months prior to inclusion; (d) identification of brain lesions on MR scan; (e) claustrophobia; or (f) presence of metal implants.
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 |
|---|---|---|
| Logistic regression (LR) prediction modelsLogistic regression model was used to establish a model to distinguish different levels of intestinal inflammation. | Diagnostic test | Crohn's disease patients with moderate-to-severe inflammation, Crohn's disease patients with no-to-mild inflammation |
Primary outcome
The area under the ROC curve (AUC) to assess the performance of diagnostic model
Time frame: 6 months
After baseline brain MRI scanning, patients were followed up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided. Disclosure is subject to application
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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. This study is not recruiting at the moment.
Xuehua Li principal investigator
Sun Yat-sen University First Affiliated Hospital Department of Radiology
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 Radiomics and Multi-omics, run by First 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuehua Li (13580364103, lxueh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the ROC curve (AUC) to assess the performance of diagnostic model (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 11 Jun 2024.