Stool DNA and occult blood testing for screen detection of colorectal neoplasia

David A. Ahlquist, Daniel J. Sargent, Charles L. Loprinzi, Theodore R. Levin, Douglas K. Rex, Dennis J. Ahnen, Kandice Knigge, Michael P Lance, Lawrence J. Burgart, Stanley R. Hamilton, James E. Allison, Michael J. Lawson, Mary E. Devens, Jonathan J. Harrington, Shauna L. Hillman

Research output: Contribution to journalArticle

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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, high-grade 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.

Original languageEnglish (US)
Pages (from-to)441-450
Number of pages10
JournalAnnals of Internal Medicine
Volume149
Issue number7
StatePublished - Oct 7 2008

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Occult Blood
DNA
Neoplasms
Adenoma
Genetic Markers
Hematologic Tests
Colonoscopy
Colorectal Neoplasms
Cross-Sectional Studies

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Ahlquist, D. A., Sargent, D. J., Loprinzi, C. L., Levin, T. R., Rex, D. K., Ahnen, D. J., ... Hillman, S. L. (2008). Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Annals of Internal Medicine, 149(7), 441-450.

Stool DNA and occult blood testing for screen detection of colorectal neoplasia. / Ahlquist, David A.; Sargent, Daniel J.; Loprinzi, Charles L.; Levin, Theodore R.; Rex, Douglas K.; Ahnen, Dennis J.; Knigge, Kandice; Lance, Michael P; Burgart, Lawrence J.; Hamilton, Stanley R.; Allison, James E.; Lawson, Michael J.; Devens, Mary E.; Harrington, Jonathan J.; Hillman, Shauna L.

In: Annals of Internal Medicine, Vol. 149, No. 7, 07.10.2008, p. 441-450.

Research output: Contribution to journalArticle

Ahlquist, DA, Sargent, DJ, Loprinzi, CL, Levin, TR, Rex, DK, Ahnen, DJ, Knigge, K, Lance, MP, Burgart, LJ, Hamilton, SR, Allison, JE, Lawson, MJ, Devens, ME, Harrington, JJ & Hillman, SL 2008, 'Stool DNA and occult blood testing for screen detection of colorectal neoplasia', Annals of Internal Medicine, vol. 149, no. 7, pp. 441-450.
Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ et al. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Annals of Internal Medicine. 2008 Oct 7;149(7):441-450.
Ahlquist, David A. ; Sargent, Daniel J. ; Loprinzi, Charles L. ; Levin, Theodore R. ; Rex, Douglas K. ; Ahnen, Dennis J. ; Knigge, Kandice ; Lance, Michael P ; Burgart, Lawrence J. ; Hamilton, Stanley R. ; Allison, James E. ; Lawson, Michael J. ; Devens, Mary E. ; Harrington, Jonathan J. ; Hillman, Shauna L. / Stool DNA and occult blood testing for screen detection of colorectal neoplasia. In: Annals of Internal Medicine. 2008 ; Vol. 149, No. 7. pp. 441-450.
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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, high-grade 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.",
author = "Ahlquist, {David A.} and Sargent, {Daniel J.} and Loprinzi, {Charles L.} and Levin, {Theodore R.} and Rex, {Douglas K.} and Ahnen, {Dennis J.} and Kandice Knigge and Lance, {Michael P} and Burgart, {Lawrence J.} and Hamilton, {Stanley R.} and Allison, {James E.} and Lawson, {Michael J.} and Devens, {Mary E.} and Harrington, {Jonathan J.} and Hillman, {Shauna L.}",
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AU - Ahlquist, David A.

AU - Sargent, Daniel J.

AU - Loprinzi, Charles L.

AU - Levin, Theodore R.

AU - Rex, Douglas K.

AU - Ahnen, Dennis J.

AU - Knigge, Kandice

AU - Lance, Michael P

AU - Burgart, Lawrence J.

AU - Hamilton, Stanley R.

AU - Allison, James E.

AU - Lawson, Michael J.

AU - Devens, Mary E.

AU - Harrington, Jonathan J.

AU - Hillman, Shauna L.

PY - 2008/10/7

Y1 - 2008/10/7

N2 - 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, high-grade 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.

AB - 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, high-grade 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.

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