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Completed

NCT Number: NCT04408703

PRognOstiC valuE of rEd Density in Ulcerative Colitis

Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imelda GI clinical research center, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of UC for at least 3 months
  • Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months
  • Ability to give informed consent by the patient or legal representative in case of minority.

Exclusion criteria

  • Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.
  • Uncontrolled coagulopathy.
  • Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy
  • Planned UC related surgery
  • Previous subtotal or total colectomy
  • Short bowel, ileostomy or colostomy
  • Pregnancy at baseline
  • Age younger than 16 years

Treatment and study plan

Red Density

Diagnostic Test

Image analysis of endoscopic images in patients with ulcerative colitis

Primary outcomes

  1. sustained clinical remission

    Time frame: week 52

    Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) <3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline.

Secondary outcomes

  1. endoscopic remission Mayo

    Time frame: week 52

    Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline.

  2. endoscopic remission UCEIS

    Time frame: week 52

    Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline.

Other outcomes

  1. correlation biomarker

    Time frame: week 52

    Correlation between RD scores and fecal calprotectin, C-reactive protein (CRP), platelet count and haemoglobin at any point in the study.

  2. correlation histological score

    Time frame: week 52

    Correlation between RD scores and Geboes histological score, the Nancy and the Robarts histological index at any point in the study.

  3. correlation endoscopic score

    Time frame: week 52

    Correlation between RD scores and Mayo endoscopic subscore and UCEIS at any point in the study.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Imelda GI Clinical Research Center
  • Sapporo Medical University

Registry information

Official study title

PRognOstiC valuE of rEd Density in Ulcerative Colitis: PROCEED-UC STUDY

Acronym: PROCEED-UC

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 29, 2020
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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