Clinical Studies

Evidence Based Medicine
 


Only Hemoccult® products provide clinical sensitivity data in their product instructions as well as numerous references in medical literature documenting their clinical performance.

Over 300 peer-reviewed articles on Hemoccult products have been published in the medical literature worldwide.

Technical Bulletins:

Hemoccult ICT Technical Bulletin (232k)

Hemoccult Clinical Sensitivity Data (97k)

All FOBTs are NOT the Same (129k)

   

Below are Summaries of Three Major Clinical Studies:
 
"Reducing Mortality From Colorectal Cancer by Screening for Fecal Occult Blood"
Mandel, J.S. et al. New England Journal of Medicine. 328:1365-1371, 1993.

Key Findings:



The first study demonstrating how annual fecal occult blood testing can reduce mortality from colorectal cancer by 33%.



This 13-year study tracked 46,551 patients between the ages of 50 and 80.



The study proved that repeat screening is the optimal method to detect premalignant polyps and colorectal cancers.

"The Effect of Fecal Occult-Blood Screening on the Incidence of Colorectal Cancer"
Mandel, J.S., et al. New England Journal of Medicine. 343:1603-1607, 2000.

Key Findings:



The first study to demonstrate that fecal occult blood testing lowers the incidence of colorectal cancer by 17-20%.


A large population of 46,551 people was tracked for 18 years.



More than 90% of people with a positive fecal occult blood test accepted follow-up colonoscopy.


Many premalignant adenomatous polyps were found in people with positive fecal occult blood tests and removed during colonoscopy.

"Screening for Colorectal Cancer With Fecal Occult Blood Testing and Sigmoidoscopy"
Winawer, S.J., et al. Journal of National Cancer Institute. 85:1311-1318, 1993.

Key Findings:



First colorectal cancer screening study reporting the benefits of combining Hemoccult FOBT and sigmoidoscopy.



Randomized controlled study of 21,756 people with 5 to 9 years of follow-up.



61 colorectal cancers were detected in FOBT group versus 21 in controls who received only sigmoidoscopy.

Most cancers found were in early stages and treatable.
   

Most cancers found were in early stages and treatable.
   

Other Key Publications regarding FOBT, Screening and CRC.
 
Clinical Efficacy

Church TR, Ederer F, Mandel JS: "Fecal occult blood screening in the Minnesota study: sensitivity of the screening test," J Natl Cancer Inst. 89(19):1440-1448, 1997.

Ederer F, Church TR, Mandel JS: "Fecal occult blood screening in the Minnesota study: role of chance detection of lesions," J Natl Cancer Inst. 89(19):1423-1428, 1997.

Hardcastle JD et al.: "Randomised controlled trial of faecal-occult-blood screening for colorectal cancer," The Lancet. 348(9040):1472-1477, 1996.

Kronborg O, et al.: "Randomised study of screening for colorectal cancer with faecal-occult-blood test," The Lancet. 348(9040):1467-1471, 1996.

Mandel JS, et al.: "The effect of fecal occult-blood screening on the incidence of colorectal cancer," N Eng J Med. 343(22):1603-1607, 2000.

Mandel JS, et al.: "Colorectal cancer mortality: Effectiveness of biennial screening for fecal occult blood," J Natl Cancer Inst. 91(5):434-437, 1999.

Mandel JS, et al.: "Reducing mortality from colorectal cancer by screening for fecal occult blood," N Eng J Med. 328(19):1365-1371, 1993.

Paaso BT: "Community-based colorectal cancer screening. An essential part of wellness for asymptomatic patients," Point of Care. 1(1):20-27, 2002.

Rennert G, et al.: "Population colorectal cancer screening with fecal occult blood test," Cancer Epidemiology, Biomarkers & Prevention. 10:1165-1168, 2001.

Winawer SJ, et al.: "Screening for colorectal cancer with fecal occult blood testing and sigmoidoscopy," J Natl Cancer Inst. 85(16):1311-1318, 1993.

Compliance/Patient Acceptance

Gaudion JR: "Colorectal cancer screening in America. An industry perspective," Point of Care. 1(1):28-29, 2002.

Cost Effectiveness / Cost Benefit

Frazier AL, et al.: "Cost-effectiveness of screening for colorectal cancer in the general population," JAMA. 284(15)1954-1961, 2000.

Lieberman DA: "Cost-effectiveness model for colon cancer screening," Gastroenterol. 109:1781-1790, 1995.

Wagner JL, et al.: "Cost effectiveness of colorectal cancer screening in the elderly," Ann Int Med. 115(10):807-817, 1991.

Walker A, Whynes DK: "Filtering strategies in mass population screening for colorectal cancer: An economic evaluation," Med Dec Making. 12(1):2-7, 1992.

CRC Screening Guidelines

Smith RA, et al.: "American Cancer Society guidelines for the early detection of cancer (2002)," CA Cancer J Clin. 52:8-22, 2002.

Winawer SJ: "A quarter century of colorectal cancer screening: progress and prospects," J Clin Oncol, Supplement. 19(18)6s-12s, 2001.

Winawer SJ, et al.: "Colorectal cancer screening: clinical guidelines and rationale," Gastroenterol. 112(2):594-642, 1997.

Diet and Patient Preparation

Rozen P, et al.: "Eliminating the need for dietary restrictions when using a sensitive guaiac fecal occult blood test," Dig Dis and Sci. 44(4):756-760, 1999.

Sinatra MA, et al.: "Interference of plant peroxidases with guaiac-based fecal occult blood tests is avoidable," Clin Chem. 45(1):123-126, 1999.

Test Method Comparison

Young GP, St John DJB: "Selecting an occult blood test for use as a screening tool for large bowel cancer," Rozen P, Reich CB, Winawer SJ (eds); Large Bowel Cancer: Policy, Prevention, Research and Treatment. In Front Gastrointest Res, Basel, Karger. 18:135-156,1991.

Foliente RL, et al.: "Colocare Self-Test versus Hemoccult II SENSA for fecal occult blood testing," Am J Gastro. 90(12):2160-2163, 1995.

Levin B, et al.: "Screening for colorectal cancer. A comparison of 3 fecal occult blood tests," Arch Intern Med. 157:970-976, 1997.

Lieberman DA, Weiss DG for the Veterans Affairs Cooperative Study Group 380: "One-time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon," N Eng J Med, 345(8):555-560, 2001.

Ostrow JD, et al.: "Sensitivity and reproducibility of chemical tests for fecal occult blood with an emphasis on false-positive reactions," Am J Digest Dis. 18(11):930-940, 1973.

Petty MT, et al.: "Readability and sensitivity of a new faecal occult blood test in a hospital ward environment. Comparison with an established test," Med J Aust. 156:420-423, 1992.

Pye G, et al.: "Comparison of Coloscreen Self-Test and Haemoccult faecal occult blood tests in the detection of colorectal cancer in symptomatic patients," Br J Surg. 77:630-631, 1990.

If you have other questions about studies related to Hemoccult products, contact your PCD sales representative.

   

References:

2. Rozen P, Knaani J, Samuel Z. Comparative screening with a sensitive guaiac and specific immunochemical occult blood test in an endoscopic study. Cancer 2000; 89:46-52

3. Rozen P, Knaani J, Samuel Z. Performance characteristics and comparison of to immunochemical and two guaiac fecal occult blood screening tests for colorectal neoplasia. Dig Dis Sci 1997; 42(10):2064-2071.

12. Young GP, St John DJB, Cole SR, Bielicki BE, et al. Prescreening evaluation of a brush-based faecal immunochemical test for haemoglobin. J Med Screen 2003; 10: 123-128.