Prospective Evaluation of Fecal Calprotectin as a Screening Biomarker for Colorectal Neoplasia

Paul John Limburg, Mary E. Devens, Jonathan J. Harrington, Nancy N. Diehl, Douglas W. Mahoney, David A. Ahlquist

Research output: Contribution to journalArticle

58 Citations (Scopus)

Abstract

OBJECTIVES: Stool testing is a well established method of screening for colorectal neoplasia. Emerging data suggest that novel biomarkers may offer performance advantages over fecal occult blood. In this large, prospective study, we assessed fecal calprotectin (a leukocyte-derived protein) as a screening biomarker for colorectal neoplasia. Fecal calprotectin was directly compared to fecal hemoglobin (Hb) and colonoscopy as the existing criterion standards for stool screening and structural evaluation, respectively. METHODS: Subjects included colonoscopy patients with a personal history of colorectal neoplasia, family history of colorectal cancer, or iron deficiency anemia. Stool specimens were collected before purgation, processed appropriately, and quantitatively analyzed for calprotectin (Nycomed Pharma, Oslo, Norway) and for Hb (Mayo Medical Laboratories, Rochester, MN) by masked technicians. Colonoscopies were performed by experienced endoscopists without prior knowledge of the fecal assay results. RESULTS: Among 412 subjects, 97 (24%) subjects had one or more colorectal neoplasms (including three with adenocarcinomas). Fecal calprotectin levels did not differ significantly between subjects with versus subjects without colorectal neoplasms (p = 0.33). Neither tumor number (p = 0.85) nor tumor size (p = 0.86) significantly influenced the observed fecal calprotectin concentrations. Estimates of the sensitivity, specificity, and positive and negative predictive values of fecal calprotectin for any colorectal neoplasms were 37%, 63%, 23%, and 76%, respectively. Comparable performance estimates for fecal Hb were 3%, 97%, 27%, and 77%, respectively. CONCLUSIONS: In this cohort of colonoscopy patients at above average risk, fecal calprotectin was a poor screening biomarker for colorectal neoplasia. Further investigation of tumor-derived, rather than blood-based, biomarkers may be a more rewarding approach to stool screening for colorectal neoplasia.

Original languageEnglish (US)
Pages (from-to)2299-2305
Number of pages7
JournalAmerican Journal of Gastroenterology
Volume98
Issue number10
DOIs
StatePublished - Oct 2003

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Leukocyte L1 Antigen Complex
Biomarkers
Colonoscopy
Colorectal Neoplasms
Neoplasms
Hemoglobins
Occult Blood
Iron-Deficiency Anemias
Norway
Adenocarcinoma
Leukocytes
Prospective Studies
Sensitivity and Specificity

ASJC Scopus subject areas

  • Gastroenterology

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Prospective Evaluation of Fecal Calprotectin as a Screening Biomarker for Colorectal Neoplasia. / Limburg, Paul John; Devens, Mary E.; Harrington, Jonathan J.; Diehl, Nancy N.; Mahoney, Douglas W.; Ahlquist, David A.

In: American Journal of Gastroenterology, Vol. 98, No. 10, 10.2003, p. 2299-2305.

Research output: Contribution to journalArticle

Limburg, Paul John ; Devens, Mary E. ; Harrington, Jonathan J. ; Diehl, Nancy N. ; Mahoney, Douglas W. ; Ahlquist, David A. / Prospective Evaluation of Fecal Calprotectin as a Screening Biomarker for Colorectal Neoplasia. In: American Journal of Gastroenterology. 2003 ; Vol. 98, No. 10. pp. 2299-2305.
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AB - OBJECTIVES: Stool testing is a well established method of screening for colorectal neoplasia. Emerging data suggest that novel biomarkers may offer performance advantages over fecal occult blood. In this large, prospective study, we assessed fecal calprotectin (a leukocyte-derived protein) as a screening biomarker for colorectal neoplasia. Fecal calprotectin was directly compared to fecal hemoglobin (Hb) and colonoscopy as the existing criterion standards for stool screening and structural evaluation, respectively. METHODS: Subjects included colonoscopy patients with a personal history of colorectal neoplasia, family history of colorectal cancer, or iron deficiency anemia. Stool specimens were collected before purgation, processed appropriately, and quantitatively analyzed for calprotectin (Nycomed Pharma, Oslo, Norway) and for Hb (Mayo Medical Laboratories, Rochester, MN) by masked technicians. Colonoscopies were performed by experienced endoscopists without prior knowledge of the fecal assay results. RESULTS: Among 412 subjects, 97 (24%) subjects had one or more colorectal neoplasms (including three with adenocarcinomas). Fecal calprotectin levels did not differ significantly between subjects with versus subjects without colorectal neoplasms (p = 0.33). Neither tumor number (p = 0.85) nor tumor size (p = 0.86) significantly influenced the observed fecal calprotectin concentrations. Estimates of the sensitivity, specificity, and positive and negative predictive values of fecal calprotectin for any colorectal neoplasms were 37%, 63%, 23%, and 76%, respectively. Comparable performance estimates for fecal Hb were 3%, 97%, 27%, and 77%, respectively. CONCLUSIONS: In this cohort of colonoscopy patients at above average risk, fecal calprotectin was a poor screening biomarker for colorectal neoplasia. Further investigation of tumor-derived, rather than blood-based, biomarkers may be a more rewarding approach to stool screening for colorectal neoplasia.

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