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Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound (PRELAPSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501758
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Alesund Hospital
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:

Rationale:

Ulcerative colitis (UC) is remitting disease with a variable course. Predicting disease relapse after remission is important for the adjustment of medical treatment. Ileocolonoscopy is the best tool for doing this, but due to its invasiveness should be replaced by a method better accepted by the patient. Gastrointestinal ultrasound (GIUS) could be such a method.The PRELAPSE study will include UC patients who have been on maintenance anti-TNF therapy for at one year or more and in clinical remission for the 3 past months at least in two centres, Haukeland University Hospital and Ålesund Hospital. The infrastructure for recruiting these patients has already been established in the BIOSTOP study (Protocol ID no: HMR2016-0.6 and EudraCT (European Clinical Trials Database) no: 2016-001409-18).

Objective:

To study if GIUS or individual US parameters can predict endoscopic relapse at follow up examinations in a group of patients with ulcerative colitis in sustained clinical and endoscopic remission

Study design:

Prospective, longitudinal, explorative, observational multi-centric study for diagnostic accuracy Study population: Adult patients with histo-pathologically confirmed diagnosis of UC between 18 and 80 years of age that have entered the BIOSTOP trial (Trial number: EudraCT: 2016-001409-18) will be considered for inclusion in the proposed study.

Intervention:

All patients will be subjected to trans-abdominal gastrointestinal ultrasound and ileocolonoscopy. Blood and faeces samples will be collected at one time point for measuring relevant inflammatory markers.

Main study parameter: Ultrasound measurements of the intestine of patients with ulcerative colitis Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will be examined repeatedly with gastrointestinal ultrasound (GIUS) and at certain time points with ileocolonoscopy or sigmoidoscopy. As all these procedures already are scheduled as a part of the BIOSTOP study the only extra burden for the patients will be the ultrasound examination. GIUS is a safe procedure that uses high frequency sound waves for the visualization of internal organs. The implementation of GIUS for the assessment of disease activity in UC patients might result in a reduced need for ileocolonoscopy, thereby reducing costs and the burden for patients. Compared to invasive endoscopic procedures GIUS can be performed without preparation, which is an advantage for the patients as treatment decisions can be made without delay. GIUS is also cheaper than ileocolonoscopy, causes little discomfort and has few or no complications.


Condition or disease Intervention/treatment
Ulcerative Colitis in Remission Ultrasound Relapse/Recurrence Diagnostic Test: Ultrasound Diagnostic Test: Analysis of prouroguanyline and uroguanyline in full blood

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Remission with treatment
Patients randomized to continue medical treatment with biologics
Diagnostic Test: Ultrasound
Transabdominal ultrasound of the bowel for categorisation of disease activity

Diagnostic Test: Analysis of prouroguanyline and uroguanyline in full blood
Withdrawal of full blood at each study visit, Storage in biobank. Analysis of prouroguanyline and proguanyline.

Remission without treatment
Patients randomized to stop medical treatment with biologics
Diagnostic Test: Ultrasound
Transabdominal ultrasound of the bowel for categorisation of disease activity

Diagnostic Test: Analysis of prouroguanyline and uroguanyline in full blood
Withdrawal of full blood at each study visit, Storage in biobank. Analysis of prouroguanyline and proguanyline.




Primary Outcome Measures :
  1. Endoscopic relapse [ Time Frame: Follow up period (24 months) ]
    Endscopic relapse defined as a MAYO endoscopic subscore ≥2


Secondary Outcome Measures :
  1. Clinical relapse [ Time Frame: Follow up period (24 months) ]
    The clinical outcome for relapse is defined as a 6 point MAYO score ≥2.

  2. Interobserver variation [ Time Frame: Follow up period (24 months) ]
    Kappa statistics for inter-observer variation of patient classification into the relapse/no relapse categories and for categorical ultrasound parameters such as the ultrasound score (0-3), vascularity with colour Doppler (0-3), stratification of wall layers (0-3), presence of haustrations (0-1), presence of submucosal thickening (0-1), lymph nodes (0-2) and free fluid.

  3. Interobserver variation [ Time Frame: Follow up period (24 months) ]
    Bland Altman statistics of the continuous ultrasound parameter wall thickness (in mm).


Other Outcome Measures:
  1. Strict endoscopic relapse [ Time Frame: Follow up period (24 months) ]
    Endscopic relapse defined as a MAYO endoscopic subscore ≥1

  2. Histological relapse [ Time Frame: Follow up period (24 months) ]
    Relapse defined as presence of inflammation evaluated by pathologist in mucosal biopsies


Biospecimen Retention:   Samples With DNA
3 ml EDTA full blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male and female patients with an established diagnosis of ulcerative colitis treated for minimum 1 year with anti-TNF maintenance therapy and in clinical remission during the last 3 months. Patients will be included from two hospitals in Norway (Haukeland University Hospital in Bergen and Ålesund Hospital in Ålesund.).
Criteria

Inclusion Criteria:

  • A confirmed diagnosis of ulcerative colitis
  • Six-point Mayo score ≤ 1
  • Two consecutive faecal calprotectin tests <200 mg/kilogram
  • Male or non-pregnant, non-nursing female

    ->18 years of age at inclusion

  • Patients treated for minimum 1 year with first-line anti-tumor necrosis factor (TNF) treatment in sustained clinical remission during the last 3 months
  • Subject capable of understanding and signing an informed consent form

Exclusion Criteria:

  • Discontinuation of systemic 5-acetylsalicylic acid (ASA) or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization
  • Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission.
  • Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy
  • Change in the anti-TNF treatment during the last 3 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
  • Use of any second-line anti-TNF medication irrespective of reason for stopping first-line anti-TNF
  • Previous failed attempts of anti-TNF discontinuation of more than 4 months' duration, with the exception of discontinuation due to pregnancy
  • Detection of anti-TNF antibodies in moderate-high titers prior to randomization
  • Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
  • Pregnancy
  • Breastfeeding
  • Participation in any other investigational medicinal Product (IMP) studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501758


Contacts
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Contact: Kim Nylund, PhD 004755975000 kim.nylund@helse-bergen.no

Locations
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Norway
Department of Medicine, Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Contact: Kim Nylund, PhD    004755975000    kim.nylund@helse-bergen.no   
Principal Investigator: Kim Nylund, PhD         
Ålesund Hospital Recruiting
Ålesund, Møre Og Romsdal, Norway
Contact: Ragnar Eriksen       Ragnar.Eriksen@helse-mr.no   
Sponsors and Collaborators
Haukeland University Hospital
Alesund Hospital
Investigators
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Principal Investigator: Kim Nylund, PhD Dep. of Medicine, Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03501758    
Other Study ID Numbers: 2017/1769
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
ulcerative colitis
ultrasound
remission
relapse
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Recurrence
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Disease Attributes