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

NCT ID: NCT00922415

Last Updated: 2010-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-12-31

Brief Summary

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 .

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

Conditions

Complicated Crohn's Disease

Keywords

Crohn's disease; calprotectin

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

cases

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dep. of Gastroenterology, Tel Aviv medical center

Locations

Dep. of Gastroenterology, Tel Aviv medical center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Iris Dotan, MD

Role: CONTACT

Phone: 972-3-6977305

Email: irisd@tasmc.health.gov.il

Facility Contacts

Iris Dotan, MD

Role: primary

Other Identifiers

255-09

Identifier Type: -

Identifier Source: secondary_id

TASMC-09-ID-255-CTIL

Identifier Type: -

Identifier Source: org_study_id