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- Title
Stool DNA and Occult Blood Testing for Screen Detection of Colorectal Neoplasia.
- Authors
Ahlquist, David A.; Sargent, Daniel J.; Loprinzi, Charles L.; Levin, Theodore R.; Rex, Douglas K.; Ahnen, Dennis J.; Knigge, Kandice; Lance, M. Peter; Burgart, Lawrence J.; Hamilton, Stanley R.; Allison, James E.; Lawson, Michael J.; Devens, Mary E.; Harrington, Jonathan J.; Hillman, Shauna L.
- Abstract
Background: Stool DNA testing is a new approach to colorectal cancer detection. Few data are available from the screening setting. Objective: To compare stool DNA and fecal blood testing for detection of screen-relevant neoplasia (curable-stage cancer, highgrade dysplasia, or adenomas >1 cm). Design: Blinded, multicenter, cross-sectional study. Setting: Communities surrounding 22 participating academic and regional health care systems in the United States. Participants: 4482 average-risk adults. Measurements: Fecal blood and DNA markers. Participants collected 3 stools, smeared fecal blood test cards and used same-day shipment to a central facility. Fecal blood cards (Hemoccult and HemoccultSensa, Beckman Coulter, Fullerton, California) were tested on 3 stools and DNA assays on 1 stool per patient. Stool DNA test 1 (SDT-1) was a precommercial 23-marker assay, and a novel test (SDT-2) targeted 3 broadly informative markers. The criterion standard was colonoscopy. Results: Sensitivity for screen-relevant neoplasms was 20% by SDT-1, 11% by Hemoccult (P = 0.020), 21% by HemoccultSensa (P = 0.80); sensitivity for cancer plus high-grade dysplasia did not differ among tests. Specificity was 96% by SDT-1, compared with 98% by Hemoccult (P < 0.001) and 97% by HemoccultSensa (P = 0.20). Stool DNA test 2 detected 46% of screen-relevant neoplasms, compared with 16% by Hemoccult (P < 0.001) and 24% by HemoccultSensa (P < 0.001). Stool DNA test 2 detected 46% of adenomas 1 cm or larger, compared with 10% by Hemoccult (P < 0.001) and 17% by HemoccultSensa (P < 0.001). Among colonoscopically normal patients, the positivity rate was 16% with SDT-2, compared with 4% with Hemoccult (P = 0.010) and 5% with HemoccultSensa (P = 0.030). Limitations: Stool DNA test 2 was not performed on all subsets of patients without screen-relevant neoplasms. Stools were collected without preservative, which reduced detection of some DNA markers. Conclusion: Stool DNA test 1 provides no improvement over HemoccultSensa for detection of screen-relevant neoplasms. Stool DNA test 2 detects significantly more neoplasms than does Hemoccult or HemoccultSensa, but with more positive results in colonoscopically normal patients. Higher sensitivity of SDT-2 was particularly apparent for adenomas.
- Subjects
BLOOD testing; COLON cancer; GENETIC markers; DNA; COLONOSCOPY; COLON examination
- Publication
Annals of Internal Medicine, 2008, Vol 149, Issue 7, p441
- ISSN
0003-4819
- Publication type
Article
- DOI
10.7326/0003-4819-149-7-200810070-00004