pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

NCT04990245 | Completed

• 1 other identifier: 200735
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Background and rationale: In ulcerative colitis, treating beyond endoscopic healing has shown a reduction of relapse and hospitalization, pushing for histological remission in daily clinical practice.1 However, very little is known on how histological remission is associated with patient reported outcomes (PROMs).2,3 In recent years, several questionnaires have been developed to assess what really matters to patients: symptoms and the burden UC exerts on them.4 As PROMs are getting more and more attention during drug development programs and drug approval by international organizations, including FDA and EMA, the link between objective outcome measures (endoscopic, histological, biochemical) and PROMs should therefore be better characterized. Objectives and design: To investigate prospectively the association of patient reported outcomes (PROMs) and biochemical, endoscopic and histological outcome measures in patients with ulcerative colitis.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; patient reported outcomes; histological scoring; disability; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• correlation between histological disease activity and disability

  histological activity is based on the Nancy score, disability is based on the IBD disk

  1 day

Secondary Outcomes (6)

• correlation between histological disease activity and patient reported outcomes

  1 day

• correlation between histological disease activity and patient reported outcomes

  1 day

• correlation between histological disease activity and patient reported outcomes

  1 day

• correlation between histological disease activity and endoscopic disease activity

  1 day

• correlation between histological disease activity and endoscopic disease activity

  1 day

Other Outcomes (1)

• correlation between histological disease activity and patient reported outcomes

  1 day

Study Arms (1)

patients with ulcerative colitis

patients with ulcerative colitis and planned endoscopy as part of routine care

Diagnostic Test: endoscopic biopsies

Interventions

endoscopic biopsies DIAGNOSTIC_TEST

patients with planned endoscopy for ulcerative colitis have endosocpic data recorded aswell as biopsy sampling and blood tests

patients with ulcerative colitis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with ulcerative colitis and planned endoscopy as part of routine care

You may qualify if:

• All patients with ulcerative colitis (≥ 16 years) undergoing planned endoscopic assessment as part of standard of care between 01.07.2020 and 30.06.2021. Evidence of a personally signed and dated informed consent document (ICF) indicating that the subject has been informed of all aspects of the study.

You may not qualify if:

• Subjects with a diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohn's disease.
• Subjects with clinical findings suggestive of CD (e.g. fistulae, granulomas on biopsy) are also excluded. Similar data collection within 8 weeks prior to endoscopic assessment

Sponsors & Collaborators

• Imelda GI Clinical Research Center: lead

Study Sites (1)

Imelda GI clinical research center

Bonheiden, 2820, Belgium

Location

Related Publications (8)

• Danese S, Roda G, Peyrin-Biroulet L. Evolving therapeutic goals in ulcerative colitis: towards disease clearance. Nat Rev Gastroenterol Hepatol. 2020 Jan;17(1):1-2. doi: 10.1038/s41575-019-0211-1. No abstract available.

  PMID: 31520081 BACKGROUND

• Colombel JF, Keir ME, Scherl A, Zhao R, de Hertogh G, Faubion WA, Lu TT. Discrepancies between patient-reported outcomes, and endoscopic and histological appearance in UC. Gut. 2017 Dec;66(12):2063-2068. doi: 10.1136/gutjnl-2016-312307. Epub 2016 Sep 2.

  PMID: 27590995 BACKGROUND

• Dragasevic S, Sokic-Milutinovic A, Stojkovic Lalosevic M, Milovanovic T, Djuranovic S, Jovanovic I, Rajic S, Stojkovic M, Milicic B, Kmezic S, Oluic B, Aleksic M, Pavlovic Markovic A, Popovic D. Correlation of Patient-Reported Outcome (PRO-2) with Endoscopic and Histological Features in Ulcerative Colitis and Crohn's Disease Patients. Gastroenterol Res Pract. 2020 Apr 2;2020:2065383. doi: 10.1155/2020/2065383. eCollection 2020.

  PMID: 32328091 BACKGROUND

• de Jong MJ, Huibregtse R, Masclee AAM, Jonkers DMAE, Pierik MJ. Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review. Clin Gastroenterol Hepatol. 2018 May;16(5):648-663.e3. doi: 10.1016/j.cgh.2017.10.019. Epub 2017 Oct 23.

  PMID: 29074448 BACKGROUND

• Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.

  PMID: 16339095 BACKGROUND

• Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Schnell P, Bernhardt CA, Mary JY, Sandborn WJ. Reliability and initial validation of the ulcerative colitis endoscopic index of severity. Gastroenterology. 2013 Nov;145(5):987-95. doi: 10.1053/j.gastro.2013.07.024. Epub 2013 Jul 25.

  PMID: 23891974 BACKGROUND

• Marchal-Bressenot A, Salleron J, Boulagnon-Rombi C, Bastien C, Cahn V, Cadiot G, Diebold MD, Danese S, Reinisch W, Schreiber S, Travis S, Peyrin-Biroulet L. Development and validation of the Nancy histological index for UC. Gut. 2017 Jan;66(1):43-49. doi: 10.1136/gutjnl-2015-310187. Epub 2015 Oct 13.

  PMID: 26464414 BACKGROUND

• Bossuyt P, Hoefkens E, Pouillon L. Prime Time Was Yesterday for Patient-reported Outcomes in Daily Care of Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1839. doi: 10.1016/j.cgh.2018.05.029. No abstract available.

  PMID: 30343866 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

intestinale biopsies

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Peter Bossuyt, MD

  Imelda general hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 4, 2021
• Study Start: July 1, 2020
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

BE (1)