Fecal Calprotectin as a Marker for Macroscopic Recurrence of Crohn's Disease After Intestinal Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00922415
First received: June 16, 2009
Last updated: December 15, 2010
Last verified: December 2010
  Purpose

our primary objective is to correlate fecal calprotectin with currently used Crohn's disease endoscopic disease activity scores used for predicting endoscopic recurrence. Our secondary objectives will be to determine a cutoff for early macroscopic recurrence of disease based on surveillance colonoscopies , and to compare this with other surrogate markers .


Condition
Complicated Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Fecal Calprotectin as a Surrogate Marker for Macroscopic Recurrence of Disease in Patients With Crohn's Disease After Intestinal Resection

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • we will check if calprotectin levels are correlated with endoscopic scores and with grade 3 or 4 Rutgeerts or CDEIS. [ Time Frame: once, at colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between calprotectin and early clinical relapse [ Time Frame: within one year ] [ Designated as safety issue: No ]
  • Correlation between calprotectin and histologic relapse [ Time Frame: within one year ] [ Designated as safety issue: No ]
  • Correlation between anti glycan antibodies and early clinical relapse [ Time Frame: within one year ] [ Designated as safety issue: No ]
  • Correlation between CDEIS and antiglycan antibodies [ Time Frame: at colonoscopy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

At all follow-up visits, they will undergo the following tests; CBC, ESR, CRP, and fecal calprotectin. Sera will be stored for antibodies such as ASCA or anti glycan antibodies.

During colonoscopy, disease recurrence will be evaluated by two scores, the Rutgeerts score and the CDEIS score, both containing 4 grades. Recurrence will be assessed by histological findings as well.


Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
cases
patients at least 18 years of age, with confirmed Crohn's disease undergoing intestinal resection for complicated Crohn's disease

Detailed Description:

Fecal calprotectin is a non invasive marker of intestinal inflammation. It is highly sensitive for the detection of active Crohn's disease (13) and mucosal healing (14). Levels higher than 250 mg/L are associated with relapse, and levels < 50 usually with remission. Mucosal healing was noted in patients with calprotectin levels less < 130 mg/L, and a mean level < 30 mg/L (13,14) .It is therefore an excellent candidate for a simple clinically available surrogate marker for endoscopic recurrence after intestinal resection in Crohn's disease. In the current study, our primary objective is to correlate fecal calprotectin with currently used Crohn's disease endoscopic disease activity scores used for predicting endoscopic recurrence. Our secondary objectives will be to determine a cutoff for early macroscopic recurrence of disease based on surveillance colonoscopies , and to compare this with other surrogate markers .

Methods This will be a prospective non-interventional observational study, performed at the Sourasky Medical center in Tel Aviv, over two years.

Patients with confirmed Crohn's disease undergoing intestinal resection for complicated Crohn's disease - will be followed for one year, and undergo a follow- up colonoscopy between 6-9 months after surgery. Patients will be seen at enrollment and follow-up visits, 3,6,9& 12 months after surgery. At enrollment, sites of disease, age of onset, smoking history and previous medication use will be registered, as well as presence of strictures and fistula, or previous surgery. At all visits, patients will be questioned regarding disease symptoms, smoking, and medication use. During each of the follow-up visits, patients will be examined, weighed, and have a disease activity index recorded. At all follow-up visits, they will undergo the following tests; CBC, ESR, CRP, and fecal calprotectin. Sera will be stored for antibodies such as ASCA or anti glycan antibodies.

During colonoscopy, disease recurrence will be evaluated by two scores, the Rutgeerts score and the CDEIS score, both containing 4 grades. Recurrence will be assessed by histological findings as well.

End points For the primary outcome, we will check if calprotecin levels are correlated with endoscopic scores. We will also evaluate cutoffs of calprotectin that are correlated with grade 3 or 4 Rutgeerts or CDEIS.

Other secondary endpoints will include:

Correlation between calprotectin and early clinical relapse (within one year) Correlation between calprotectin and histologic relapse (within one year) Correlation between anti glycan antibodies and early clinical relapse (within one year) Correlation between CDEIS and antiglycan antibodies

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients at least 18 years of age, with confirmed Crohn's disease undergoing intestinal resection for complicated Crohn's disease

Criteria

Inclusion Criteria:

  • at least 18 years of age
  • confirmed Crohn's disease
  • undergoing intestinal resection for complicated Crohn's disease

Exclusion Criteria:

  • Ileostomy
  • pregnancy
  • stricturoplasty without resection
  • patients with diffuse active disease at other sites
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922415

Contacts
Contact: Iris Dotan, MD 972-3-6977305 irisd@tasmc.health.gov.il

Locations
Israel
Dep. of Gastroenterology, Tel Aviv medical center Recruiting
Tel Aviv, Israel
Contact: Iris Dotan, MD    972-3-6977305    Irisd@tasmc.health.gov.il   
Principal Investigator: Iris Dotan, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Dr. Iris Dotan, Dep. of Gastroenterology, Tel Aviv medical center
ClinicalTrials.gov Identifier: NCT00922415     History of Changes
Other Study ID Numbers: TASMC-09-ID-255-CTIL, 255-09
Study First Received: June 16, 2009
Last Updated: December 15, 2010
Health Authority: Israel: The Israel National Institute for Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Crohn's disease
calprotectin

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014