Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes (AIFOR-CD)
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 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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Helene Petitjean P. Clinical Study Director, MD
- 전화번호: +1 609 375 2003
- 이메일: info@pharmaenst.com
연구 연락처 백업
- 이름: Li Chen, Study Director, Ph.D.
- 전화번호: +1 609 375 2003
- 이메일: info@pharmaenst.com
연구 장소
-
-
Andalusia
-
Seville, Andalusia, 스페인, 41013
- Hospital Universitario Virgen del Rocío
-
연락하다:
- Manuel Romero Gomez, MD
- 전화번호: +34 955 01 20 00
- 이메일: mromerogomez@us.es
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Patients with surgical intervention 6-24 Months after index biopsy
Patients with with CD and ileal biopsy that underwent a first ileal surgical resection for ileal fibro-stenotic Crohn's disease within a minimum of 6 months and 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.
|
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.
|
|
Patients without surgical intervention within 4 years after index biopsy
Patients with CD 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
First ileal surgical resection for ileal fibro-stenotic Crohn's
기간: 24 months
|
First ileal surgical resection for ileal fibro-stenotic Crohn's , and No endoscopic procedure (balloon dilation, strictureplasty or stricturectomy)
|
24 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Manuel Romero Gomes, MD, Hospital Universitario Virgen del Rocio, Seville Spain
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- PHN 1-062-26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .