Inflammatory Bowel DiseasesNCT05168917
EURECA (EUropeanRElapseCAlprotectin) Study
A study testing LIAISON Calprotectin in people with Inflammatory Bowel Diseases, run by DiaSorin Inc. at 3 sites in 3 countries.
Trial summary
This study will investigate the correlation of fecal calprotectin (FC) values to quiescent ulcerative colitis and to disease activity (relapse) as assessed by clinical data and endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- LIAISON Calprotectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 2 Jun 2017to 13 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults,18 years and older, either genders
- Subject previously diagnosed with left-sided colitis or pancolitis based on endoscopy and, if available, confirmed by histological examination of biopsy taken during endoscopy
- Subject in clinical and endoscopic remission. Remission will be documented by proctosigmoidoscopy.
- Subject who may receive maintenance therapy as per current medical practice, e.g. mesalazine, corticosteroids, azathioprine, anti-TNF
- Availability of stool specimen for basal time point
- Subject willing and able to sign, the approved Informed Consent Form for this project in accordance with international and national regulations
- Subject able to understand and follow study procedures
Who cannot join
- Any subject that does not meet the inclusion criteria
- Subject with microscopic colitis
- Subject with Crohn's disease
- Subject with limited proctitis
- Subject with severe chronic disease affecting the possibility to comply with the study protocol (i.e. severe cardiovascular disease, renal or liver failure, neurologic disease, hematological disease and mental disorder)
- Subject who is regularly taking oral anticoagulants
Show all 9Show fewer
- Subject who is currently pregnant or lactating
- Subject unable or unwilling to subscribe informed consent
- Subject unable or unwilling to perform required study procedures
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site
Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology
Nancy
Italy1 site
Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia
Milan
About this study
Official title: EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis
This study will investigate the correlation of fecal calprotectin (FC) values to quiescent ulcerative colitis and to disease activity (relapse) as assessed by clinical data and endoscopy.
Read the detailed description
The study is prospective with a longitudinal approach. About 200 patients will be followed every 3 to 12 months (at basal, 3, 6, 9 and 12 months alternating visits to telephone contacts) and subsequently for further 6 months in 3 different sites (competitive enrollment, 1site/country, Italy, France and Spain respectively). Fecal samples for immunoassays will be collected at follow up visits, stored frozen (-20°C) and sent to testing lab for their determination.
The following assessments are foreseen:
Clinical history and demography (screening), Proctosigmoidoscopy (basal), Hemochromo with WBC differential count, C-reactive protein (every 6 months from screening up to 12 months; relapse), Coagulation (screening) Specimen collection for fecal calprotectin determination (within 1-2 weeks from Informed Consent signature; for basal time point; every next 3 months from basal up to 12 months and at month 18; relapse), Coproculture for Salmonella, Shigella, E. Coli and Campylobacter (relapse), Pharmacological ongoing therapy, Mayo score (each time point; relapse)
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- LIAISON Calprotectin
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIAISON CalprotectinDiagnostic test
Immunoassay for fecal calprotectin measurement
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis in clinical and endoscopic remission | Other | Patients with established diagnosis of ulcerative colitis (UC) in clinical and endoscopic remission defined as clinical score = 0 at enrollment with no endoscopy flare up may participate to follow up. Proctosigmoidoscopy to document endoscopic remission has to be foreseen. The patients' inclusion/exclusion criteria are based on the established diagnostic procedures for the UC, i.e. colonoscopy at the time of diagnosis, endoscopic evidence of remission and clinical significant findings. Receives: Diagnostic Test: LIAISON Calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Sensitivity and 95% Confidence Interval (exact method)
Computed and compared to the clinical diagnosis
Measured: Through study completion, an average of 36 months
Clinical Specificity and 95% Confidence Interval (exact method)
Computed and compared to the clinical diagnosis
Measured: Through study completion, an average of 36 months
Positive Predictive Value and 95% Confidence Interval (exact method)
Computed and compared to the clinical diagnosis
Measured: Through study completion, an average of 36 months
Kaplan-Meier survival curve
Percent variation from one time point to the following one will computed and compared to the disease evolution determined by the clinician for each subject. This curve will be used to determine the ability of the calprotectin value at the time of subject recruitment to predict the relapse.
Measured: Through study complete, an average of 36 months
Secondary outcomes (1)
ROC Analysis and the relevant plots
Analysis will determine if the assay was assigned with appropriate cut-off value
Measured: Through study completion, an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start2 Jun 2017
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Basal visit and follow up visits at 3,9,and 18 months in which stool specimens wil be collected.
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaSorin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Malesci, Professor, Study director, Istituto Clinico Humanitas, Head of Gastroenterology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168917
- Sponsor's protocol ID
- CLI-PR-1601
- Status last verified
- Jan 2022
- First submitted
- 10 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fiorino G, Danese S, Peyrin-Biroulet L, Sans M, Bonelli F, Calleri M, Zierold C, Pollastro R, Moretti F, Malesci A. LIAISON(R) Calprotectin for the prediction of relapse in quiescent ulcerative colitis: The EuReCa study. United European Gastroenterol J. 2022 Oct;10(8):836-843. doi: 10.1002/ueg2.12268. Epub 2022 Jul 4.
PubMed 35789124
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05168917
- Acronym / sponsor ID
- CLI-PR-1601
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- DiaSorin Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the correlation of fecal calprotectin (FC) values to quiescent ulcerative colitis and to disease activity (relapse) as assessed by clinical data and endoscopy.
Detailed description
The study is prospective with a longitudinal approach. About 200 patients will be followed every 3 to 12 months (at basal, 3, 6, 9 and 12 months alternating visits to telephone contacts) and subsequently for further 6 months in 3 different sites (competitive enrollment, 1site/country, Italy, France and Spain respectively). Fecal samples for immunoassays will be collected at follow up visits, stored frozen (-20°C) and sent to testing lab for their determination.
The following assessments are foreseen:
Clinical history and demography (screening), Proctosigmoidoscopy (basal), Hemochromo with WBC differential count, C-reactive protein (every 6 months from screening up to 12 months; relapse), Coagulation (screening) Specimen collection for fecal calprotectin determination (within 1-2 weeks from Informed Consent signature; for basal time point; every next 3 months from basal up to 12 months and at month 18; relapse), Coproculture for Salmonella, Shigella, E. Coli and Campylobacter (relapse), Pharmacological ongoing therapy, Mayo score (each time point; relapse)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Basal visit and follow up visits at 3,9,and 18 months in which stool specimens wil be collected.
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis in clinical and endoscopic remission | Other | Diagnostic Test: LIAISON CalprotectinPatients with established diagnosis of ulcerative colitis (UC) in clinical and endoscopic remission defined as clinical score = 0 at enrollment with no endoscopy flare up may participate to follow up. Proctosigmoidoscopy to document endoscopic remission has to be foreseen. The patients' inclusion/exclusion criteria are based on the established diagnostic procedures for the UC, i.e. colonoscopy at the time of diagnosis, endoscopic evidence of remission and clinical significant findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults,18 years and older, either genders
- Subject previously diagnosed with left-sided colitis or pancolitis based on endoscopy and, if available, confirmed by histological examination of biopsy taken during endoscopy
- Subject in clinical and endoscopic remission. Remission will be documented by proctosigmoidoscopy.
- Subject who may receive maintenance therapy as per current medical practice, e.g. mesalazine, corticosteroids, azathioprine, anti-TNF
- Availability of stool specimen for basal time point
Key exclusion criteria (9 listed)
- Any subject that does not meet the inclusion criteria
- Subject with microscopic colitis
- Subject with Crohn's disease
- Subject with limited proctitis
- Subject with severe chronic disease affecting the possibility to comply with the study protocol (i.e. severe cardiovascular disease, renal or liver failure, neurologic disease, hematological disease and mental disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIAISON CalprotectinImmunoassay for fecal calprotectin measurement | Diagnostic test | Ulcerative colitis in clinical and endoscopic remission |
Primary outcome
Clinical Sensitivity and 95% Confidence Interval (exact method)
Time frame: Through study completion, an average of 36 months
Computed and compared to the clinical diagnosis
Clinical Specificity and 95% Confidence Interval (exact method)
Time frame: Through study completion, an average of 36 months
Computed and compared to the clinical diagnosis
Positive Predictive Value and 95% Confidence Interval (exact method)
Time frame: Through study completion, an average of 36 months
Computed and compared to the clinical diagnosis
Kaplan-Meier survival curve
Time frame: Through study complete, an average of 36 months
Percent variation from one time point to the following one will computed and compared to the disease evolution determined by the clinician for each subject. This curve will be used to determine the ability of the calprotectin value at the time of subject recruitment to predict the relapse.
1 secondary outcome
ROC Analysis and the relevant plots
Time frame: Through study completion, an average of 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 35789124Fiorino G, Danese S, Peyrin-Biroulet L, Sans M, Bonelli F, Calleri M, Zierold C, Pollastro R, Moretti F, Malesci A. LIAISON(R) Calprotectin for the prediction of relapse in quiescent ulcerative colitis: The EuReCa study. United European Gastroenterol J. 2022 Oct;10(8):836-843. doi: 10.1002/ueg2.12268. Epub 2022 Jul 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Malesci, Professor study director
Istituto Clinico Humanitas, Head of Gastroenterology Department
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIAISON Calprotectin in people with Inflammatory Bowel Diseases, run by DiaSorin Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Sensitivity and 95% Confidence Interval (exact method) (time frame: Through study completion, an average of 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.