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

June 16, 2009
December 15, 2010
August 2009
August 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00922415 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Fecal Calprotectin as a Marker for Macroscopic Recurrence of Crohn's Disease After Intestinal Resection
Use of Fecal Calprotectin as a Surrogate Marker for Macroscopic Recurrence of Disease in Patients With Crohn's Disease After Intestinal Resection

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 .

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

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

Complicated Crohn's Disease
Not Provided
cases
patients at least 18 years of age, with confirmed Crohn's disease undergoing intestinal resection for complicated Crohn's disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Iris Dotan, MD 972-3-6977305 irisd@tasmc.health.gov.il
Israel
 
NCT00922415
TASMC-09-ID-255-CTIL, 255-09
No
Dr. Iris Dotan, Dep. of Gastroenterology, Tel Aviv medical center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP