Crohn DiseaseAIFOR-CDNCT07795476
Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes
An observational study of Crohn Disease and Fibrostenotic Crohn's Disease, run by PharmaNest, Inc at 2 sites in Spain.
Trial summary
The goal of this retrospective observational study is to learn whether artificial intelligence-based digital pathology can measure intestinal fibrosis and help identify patients with Crohn's disease who may be at greater risk of disease progression and surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Fibrostenotic Crohn's Disease, CD - Crohn's Disease
- What is being tested?
- Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Nov 2026to 15 May 2027
- 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 consists of adults (≥18 years) with a diagnosis of Crohn's disease and an available ileal endoscopic biopsy suitable for digital pathology analysis. The overall AIFOR-CD population includes patients spanning varying degrees of mucosal fibrosis and disease characteristics. For the outcomes component, patients without prior gastrointestinal surgery or endoscopic intervention are selected according to whether they underwent a first ileal surgical resection for fibrostenotic Crohn's disease within 6-24 months after the index biopsy or remained free of ileal resection or endoscopic intervention for at least 4 years after the index biopsy.
Who may be able to join
- Adult pts (>=18 years old) diagnosed with Crohn's disease based on Investigator's assessment.
- Ileal biopsy with fibrosis Masson's Trichome staining available for digitization or already digitized at 40X ( or ~0.25micron per pixel)
- The cohort will contain patients with various levels of intensity and distribution of fibrosis as defined by the pathologist with a minimum of 7 patients for any level of intensity and distribution for being required.
- Minimum information available for each patient (see Appendix 2, table 1)
Who cannot join
- History of gastrointestinal endoscopic interventions and/or surgery for Crohn's disease management such as endoscopic balloon dilation, strictureplasty, stricturectomy or bowel resection prior to the index biopsy.
- History of gastrointestinal surgery for any indication
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
University Hospital Virgen del Rocio
Seville, Andalusia, 41013
Manuel Romero Gomez, MD, +34 955 01 20 00, mromerogomez@us.es
University Hosptal Virgen Macarena
Seville
Frederico Arguelles Arias, MD, +34 955 00 80 00, farguelles1@us.es
About this study
The goal of this retrospective observational study is to learn whether artificial intelligence-based digital pathology can measure intestinal fibrosis and help identify patients with Crohn's disease who may be at greater risk of disease progression and surgery.
The main questions the study aims to answer are:
Read more
Does the FibroNest Phenotypic Fibrosis Composite Score [Ph-FCS(Muc)], measured from routinely collected ileal biopsies, reflect the severity of fibrosis assessed by a pathologist?
- Is Ph-FCS(Muc) associated with Crohn's disease characteristics and history?
- Can Ph-FCS(Muc) help predict whether a patient will subsequently require a first ileal surgical resection for fibrostenotic Crohn's disease?
Researchers will retrospectively analyze previously collected ileal biopsies and medical information from adults with Crohn's disease. Biopsy slides will be digitized and analyzed using FibroNest digital pathology, and the resulting fibrosis measurements will be compared with pathologist assessments, clinical characteristics, disease history, and subsequent clinical outcomes.
Read the detailed description
Crohn's disease is a chronic inflammatory bowel disease that can lead to progressive intestinal fibrosis. Fibrosis contributes to structural bowel damage, strictures and obstruction and is an important cause of surgical intervention. However, intestinal fibrosis remains difficult to quantify objectively, particularly from routinely collected endoscopic biopsies, and there are limited validated tools to identify tissue fibrosis phenotypes associated with subsequent disease progression.
AIFOR-CD (Artificial Intelligence for Outcomes Research in Crohn's Disease) is a retrospective observational study evaluating the use of artificial intelligence-based digital pathology to quantify and characterize fibrosis in routinely collected ileal biopsies from patients with Crohn's disease.
The study uses the FibroNest Phenotypic Fibrosis Composite Score [Ph-FCS(Muc)], a continuous quantitative digital pathology biomarker derived from histological features of fibrosis measured in the mucosa of ileal biopsies. The study is organized around three complementary objectives: to validate Ph-FCS(Muc) against pathologist-assessed mucosal fibrosis severity; to investigate its relationship with Crohn's disease characteristics and history; and to explore whether quantitative fibrosis phenotypes in ileal biopsies can identify patients at increased risk of subsequent first ileal surgical resection for fibrostenotic Crohn's disease.
The study will use previously collected histological specimens and retrospective clinical information. Digital pathology analyses will be performed using pseudonymized whole-slide images of ileal biopsies, with appropriate blinding between biomarker measurements and the reference assessments or clinical outcomes when applicable.
AIFOR-CD is intended to determine whether quantitative assessment of fibrosis from routinely obtained endoscopic biopsies can provide objective information on intestinal fibrotic burden and contribute to the characterization and risk stratification of patients with Crohn's disease.
- Being tested
- Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker
- Keywords
- Digital Pathology, Fibrosis, Artificial Intelligence
- Medical subject headings
- Crohn Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ph-FCS(Muc) fibrosis severity Digital Pathology biomarkerDiagnostic test
Ph-FCS(Muc) is a continuous, quantitative digital pathology biomarker that integrates multiple histological features of mucosal fibrosis into a single fibrosis severity score, providing a more granular assessment than conventional ordinal histological staging.
| Study group | Role | What they receive |
|---|---|---|
| Patients with surgical intervention 24 Months after index biopsy | Patients with with Crohn's Disease (CD) and ileal biopsy that underwent a first ileal surgical resection for ileal fibro-stenotic Crohn's disease within a maximum of 24 months after the index biopsy. No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) is permitted between the index biopsy and the first ileal surgical resection. Receives: Diagnostic Test: Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker | |
| Patients without surgical intervention within 4 years after index biopsy | Patients with Crohn's Disease and ileal biopsy that did NOT undergo first ileal resection or ileal endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) within 4 years after the index biopsy. Receives: Diagnostic Test: Ph-FCS(Muc) fibrosis severity Digital Pathology biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of the First ileal surgical resection for ileal fibro-stenotic Crohn's
Occurrence (and date of occurrence) of the First ileal surgical resection for ileal fibro-stenotic Crohn's , and No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaNest, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital of Nuestra Señora de Valve, University Hospital of Virgen del Rocio, University Hospital of Virgen Macarena
- Responsible party
- Sponsor
- Investigators
- Manuel Romero Gomes, MD, Principal investigator, Hospital Universitario Virgen del Rocio, Seville Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795476
- Sponsor's protocol ID
- PHN 1-062-26
- Acronym
- AIFOR-CD
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Denise Ng et al. (2026). Digital Pathology Quantifies Mucosal Fibrosis and Aligns with Pathologist Scoring in IBD Biopsies; Submitted UEG 2026 (refused on the basis of small N=20) and resubmitted DDW2027
Chen Li et al. (2026) Evaluation of a Novel Structured, Layer-Specific Framework for Histologic Fibrosis Staging in IBD. Chen L. et Al. Gastrointestinal Endoscopy, Vol. 103, Issue 5, Supplement S-1055-S-1056, May, 2026 - doi. 10.1016/S0016-5107(26)02658-1-
Miha Jerala, Chen L, Drobne D, Petitjean M, Zidar N. Quantifying fibrosis in inflammatory bowel diseases - contribution of digital pathology. Dig Liver Dis. 2025 Oct;57(10):1938-1946. doi: 10.1016/j.dld.2025.08.002. Epub 2025 Aug 20.
PubMed 40841237
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07795476
- Acronym / sponsor ID
- AIFOR-CD / PHN 1-062-26
- Keywords
- Digital Pathology, Fibrosis, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PharmaNest, IncIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital of Nuestra Señora de Valve, University Hospital of Virgen del Rocio, University Hospital of Virgen Macarena
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 31 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.
The goal of this retrospective observational study is to learn whether artificial intelligence-based digital pathology can measure intestinal fibrosis and help identify patients with Crohn's disease who may be at greater risk of disease progression and surgery.
The main questions the study aims to answer are:
Does the FibroNest Phenotypic Fibrosis Composite Score [Ph-FCS(Muc)], measured from routinely collected ileal biopsies, reflect the severity of fibrosis assessed by a pathologist?
- Is Ph-FCS(Muc) associated with Crohn's disease characteristics and history?
- Can Ph-FCS(Muc) help predict whether a patient will subsequently require a first ileal surgical resection for fibrostenotic Crohn's disease?
Researchers will retrospectively analyze previously collected ileal biopsies and medical information from adults with Crohn's disease. Biopsy slides will be digitized and analyzed using FibroNest digital pathology, and the resulting fibrosis measurements will be compared with pathologist assessments, clinical characteristics, disease history, and subsequent clinical outcomes.
Detailed description
Crohn's disease is a chronic inflammatory bowel disease that can lead to progressive intestinal fibrosis. Fibrosis contributes to structural bowel damage, strictures and obstruction and is an important cause of surgical intervention. However, intestinal fibrosis remains difficult to quantify objectively, particularly from routinely collected endoscopic biopsies, and there are limited validated tools to identify tissue fibrosis phenotypes associated with subsequent disease progression.
AIFOR-CD (Artificial Intelligence for Outcomes Research in Crohn's Disease) is a retrospective observational study evaluating the use of artificial intelligence-based digital pathology to quantify and characterize fibrosis in routinely collected ileal biopsies from patients with Crohn's disease.
The study uses the FibroNest Phenotypic Fibrosis Composite Score [Ph-FCS(Muc)], a continuous quantitative digital pathology biomarker derived from histological features of fibrosis measured in the mucosa of ileal biopsies. The study is organized around three complementary objectives: to validate Ph-FCS(Muc) against pathologist-assessed mucosal fibrosis severity; to investigate its relationship with Crohn's disease characteristics and history; and to explore whether quantitative fibrosis phenotypes in ileal biopsies can identify patients at increased risk of subsequent first ileal surgical resection for fibrostenotic Crohn's disease.
The study will use previously collected histological specimens and retrospective clinical information. Digital pathology analyses will be performed using pseudonymized whole-slide images of ileal biopsies, with appropriate blinding between biomarker measurements and the reference assessments or clinical outcomes when applicable.
AIFOR-CD is intended to determine whether quantitative assessment of fibrosis from routinely obtained endoscopic biopsies can provide objective information on intestinal fibrotic burden and contribute to the characterization and risk stratification of patients with Crohn's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with surgical intervention 24 Months after index biopsy | – | Diagnostic Test: Ph-FCS(Muc) fibrosis severity Digital Pathology biomarkerPatients with with Crohn's Disease (CD) and ileal biopsy that underwent a first ileal surgical resection for ileal fibro-stenotic Crohn's disease within a maximum of 24 months after the index biopsy. No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) is permitted between the index biopsy and the first ileal surgical resection. |
| Patients without surgical intervention within 4 years after index biopsy | – | Diagnostic Test: Ph-FCS(Muc) fibrosis severity Digital Pathology biomarkerPatients with Crohn's Disease and ileal biopsy that did NOT undergo first ileal resection or ileal endoscopic procedure (balloon dilation, strictureplasty or stricturectomy) within 4 years after the index biopsy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults (≥18 years) with a diagnosis of Crohn's disease and an available ileal endoscopic biopsy suitable for digital pathology analysis. The overall AIFOR-CD population includes patients spanning varying degrees of mucosal fibrosis and disease characteristics. For the outcomes component, patients without prior gastrointestinal surgery or endoscopic intervention are selected according to whether they underwent a first ileal surgical resection for fibrostenotic Crohn's disease within 6-24 months after the index biopsy or remained free of ileal resection or endoscopic intervention for at least 4 years after the index biopsy.
Key inclusion criteria (4 listed)
- Adult pts (>=18 years old) diagnosed with Crohn's disease based on Investigator's assessment.
- Ileal biopsy with fibrosis Masson's Trichome staining available for digitization or already digitized at 40X ( or ~0.25micron per pixel)
- The cohort will contain patients with various levels of intensity and distribution of fibrosis as defined by the pathologist with a minimum of 7 patients for any level of intensity and distribution for being required.
- Minimum information available for each patient (see Appendix 2, table 1)
Key exclusion criteria (2 listed)
- History of gastrointestinal endoscopic interventions and/or surgery for Crohn's disease management such as endoscopic balloon dilation, strictureplasty, stricturectomy or bowel resection prior to the index biopsy.
- History of gastrointestinal surgery for any indication
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 |
|---|---|---|
| Ph-FCS(Muc) fibrosis severity Digital Pathology biomarkerPh-FCS(Muc) is a continuous, quantitative digital pathology biomarker that integrates multiple histological features of mucosal fibrosis into a single fibrosis severity score, providing a more granular assessment than conventional ordinal histological staging. | Diagnostic test | Patients with surgical intervention 24 Months after index biopsy, Patients without surgical intervention within 4 years after index biopsy |
Primary outcome
Occurrence of the First ileal surgical resection for ileal fibro-stenotic Crohn's
Time frame: 24 months
Occurrence (and date of occurrence) of the First ileal surgical resection for ileal fibro-stenotic Crohn's , and No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy)
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 1 Oct 2026.
- BackgroundDenise Ng et al. (2026). Digital Pathology Quantifies Mucosal Fibrosis and Aligns with Pathologist Scoring in IBD Biopsies; Submitted UEG 2026 (refused on the basis of small N=20) and resubmitted DDW2027
- BackgroundChen Li et al. (2026) Evaluation of a Novel Structured, Layer-Specific Framework for Histologic Fibrosis Staging in IBD. Chen L. et Al. Gastrointestinal Endoscopy, Vol. 103, Issue 5, Supplement S-1055-S-1056, May, 2026 - doi. 10.1016/S0016-5107(26)02658-1-
- Results publication: PubMed 40841237Miha Jerala, Chen L, Drobne D, Petitjean M, Zidar N. Quantifying fibrosis in inflammatory bowel diseases - contribution of digital pathology. Dig Liver Dis. 2025 Oct;57(10):1938-1946. doi: 10.1016/j.dld.2025.08.002. Epub 2025 Aug 20.
- Individual participant dataSharing planned: Undecided
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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.
Manuel Romero Gomes, MD principal investigator
Hospital Universitario Virgen del Rocio, Seville Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Fibrostenotic Crohn's Disease, run by PharmaNest, Inc at 2 sites in Spain.
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 4 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Helene Petitjean P. Clinical Study Director, MD (+1 609 375 2003, info@pharmaenst.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of the First ileal surgical resection for ileal fibro-stenotic Crohn's (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07795476, which also lists 3 linked publications.
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 1 Oct 2026.