Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With Inflammatory Bowel Disease

February 25, 2019 updated by: Katrine Carlsen, Herlev Hospital

Development of a New Algorithm to Determine the Activity of Disease: Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With IBD.

We hypothesize that the number of needed endoscopic procedure performed at IBD patients (adult and children), can be reduced by using an individualized algorithm of symptoms, blood and faecal biomarkers.

The aim of the study is to reduce the numbers of endoscopies, as the procedure is uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we want to construct an algorithm by which the intestinal healing can be foreseen without performing an endoscopy.

Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score, with the histo-pathological inflammation score from intestinal biopsies and the immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order to assess the gold standard - endoscopic remission.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Deep remission: The treatment goal in patiens with IBD is to achieve deep remission before drug withdrawal to avoid relapse. In order to evaluate the healing of mucosa, it is currently necessary to carry out an endoscopy, despite the additional information provided by FC and blood samples. The endoscopic procedure is uncomfortable for the patient, time consuming and expensive. We therefore seek, on the basis of existing knowledge and using a correlation between FC, blood tests and clinical remission with endoscopic findings, to establish some non-invasive biomarkers that might express deep remission. In the long run, threshold levels will be used as indicators for performing an endoscopy and, hopefully, reduce the need for it to be performed. We will compare the results from children and adults because it is likely there exist differences in their respective FC levels.

Histopathologic remission: Biopsies of the intestinal tissue can be evaluated histopathologically and indicate the level of microscopic inflammation and can assess the acute and chronic inflammatory signs at the cellular level, e.g. altered glandular structure, crypt abscess and ulcerations. By using the Karl Geboes grading system, microscopic histopathological deep remission can be assessed. We will explore the endoscopic 'gold standard' by comparing endoscopic remission with histopathological remission.

Immunological remission: In general, tissue factors are linked to various immunological pathways belonging to the innate, adaptive and regulatory immune response, comprising a pro-inflammatory and an anti-inflammatory response. This includes molecules such as cytokines, chemokines, adhesion molecules and their corresponding cellular and soluble receptors. Tumor-necrosis-factor (TNF)-alpha and interleukin 17A is two of several molecules in the pro-inflammatory process that is strongly associated with the grade of inflammation in IBD (Florholmen and Fries 2011). Olsen et al. 2009 have reported that a normalization of mucosal TNF-alpha in most ulcerative colitis patients will represent an endoscopically healed mucosa.

In addition to clinical indexes, endoscopic and histological criteria, we also introduce a molecular based Immunological Remission. A working hypothesis is that immunological remission is a state of normalization of the pro-inflammatory and anti-inflammatory processes in mucosa. The concept of immunological remission and the potential clinical impact are still in the early phases of evaluation, and to obtain a practical application a non-invasive test, such as one based on a stool sample, must be developed. In the current project, immunological remission will be a part of this study, as endoscopic and histopathology remission, with correlation to FC, blood tests and clinical remission.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Katrine Carlsen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 67 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy).

Description

Inclusion Criteria:

  • Patients scheduled for endoscopy
  • Age 0 - 67 years
  • Intestinal infections ruled out by stool sample analysis for pathogenic bacteria, parasites and Clostridium difficile
  • CMV ruled out
  • Fluent in Danish

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) score III or above
  • Patients who are alcohol or drug abusers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Adults and children with and without IBD

The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy).

Inclusion of adult patients, age 15-67 years: 50 patients with UC in remission, 50 patients with active UC, 50 patients without IBD

Inclusion of pediatric patients, <15 years: We expect to include: 10 UC / CD patients in remission,10 UC / CD patients in relapse,10 non-IBD patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fecal Calprotectin (FC)and clinical score
Time Frame: Two FC test will be analysed up to 1 week before the endoscopy. SCCAI will be collected up to 1 week before endoscopy.

FC is an inflammation marker from intestinal mucosa.

Clinical score by Simple Clinical Colitis Activity Index, SCCAI. SCCAI is a specific Ulcerative Colitis index.
Two FC test will be analysed up to 1 week before the endoscopy. SCCAI will be collected up to 1 week before endoscopy.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Histopathological and Immunological inflammation score
Time Frame: up to 8 weeks after endoscopy

Histopathological inflammation: intestinal biopsies assessed by Karl Geboes score.

Immunological score: TNF- alpha and Interleukin 17 A levels in intestinal biopsies assessed by PCR analysis
up to 8 weeks after endoscopy

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Endoscopic-, Histopathological- and Immunological- intestinal inflammation in children with IBD
Time Frame: Up to 2 years after endoscopy
Comparing the results of endoscopic-, histopathological- and immunological-intestinal inflammation in children versus adults with IBD.
Up to 2 years after endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital of North Norway
Hvidovre University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katrine Carlsen, MD, Departmen of Gastroenterology, Herlev University Hospital
  • Study Director: Pia Munkholm, Professor, Department of Gastroenterology, Herlev University Hospital
  • Study Chair: Vibeke Wewer, MD, Phd, Hvidovre University Hospital
  • Study Chair: Lene Riis, MD, PhD, Department of Pathology, Herlev University Hospital
  • Study Chair: Christian Jakobsen, MD, PhD, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DER-SBIO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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