Evidence map›Paper›PMID 18838724›Full record

Trial reportAnnals of internal medicine2008

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, M Peter Lance, Lawrence J Burgart, Stanley R Hamilton and 5 more

2 registry-linked trialsAbstract readClinical TrialComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of internal medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 109 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 8 pooled it
15.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06342440 recruitingnot on this mapstarted 2020, after this paper: background citation

A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer

TypeobservationalSponsorCity of Hope Medical CenterRan2020 to 2028Enrolled2,000ConditionsColorectal Cancer, Colorectal Neoplasms, Colorectal Polyp, Colorectal AdenocarcinomaArmsDENEB
NCT07450612 recruitingnot on this mapstarted 2024, after this paper: background citation

Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection

TypeobservationalSponsorSan Raffaele UniversityRan2024 to 2031Enrolled1,200ConditionsColorectal Cancer, Adenoma Colon, Adenoma Colon Polyp, Colon AdenomaArmsBEACON
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 8 syntheses or guidelines pooled it, 277 citations in OpenAlex.

  1. Pooled it
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  4. Guideline
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  6. Pooled it
  7. Colorectal Cancer Screening in Average Risk Populations: Evidence Summary.Canadian journal of gastroenterology & hepatology · 2016
    Pooled it
  8. Diagnostic value of stool DNA testing for multiple markers of colorectal cancer and advanced adenoma: a meta-analysis.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2013
    Pooled it
  9. Trial
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  11. Trial
  12. Article
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  15. Review
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49 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 1 country.

David A AhlquistMayo Clinic, Rochester, Minnesota 55905, USA. ahlquist.david@mayo.edu
Daniel J Sargent
Charles L Loprinzi
Theodore R Levin
Douglas K Rex
Dennis J Ahnen
Kandice Knigge
M Peter Lance
Lawrence J Burgart
Stanley R Hamilton
James E Allison
Michael J Lawson
Mary E Devens
Jonathan J Harrington
Shauna L Hillman
Kaiser Permanente · USMayo Clinic · USUniversity of Portland · USArizona Science Center · USUniversity of Arizona · USUniversity of Colorado Health · US

Funding

SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
COLORECTAL CANCER SCREENING--FECAL BLOOD VS DNAU01CA089389 · NCI · MAYO CLINIC COLL OF MEDICINE, ROCHESTER · PI AHLQUIST, DAVID A · 2001 to 2004
$6.5M
NCI NIH HHS U01 CA089389NCI NIH HHS U01 CA 37404NCI NIH HHS U01 CA 89389NCI NIH HHS U10 CA037404
6 · The paper itself

Abstract

backgroundStool DNA testing is a new approach to colorectal cancer detection. Few data are available from the screening setting.

objectiveTo compare stool DNA and fecal blood testing for detection of screen-relevant neoplasia (curable-stage cancer, high-grade dysplasia, or adenomas >1 cm).

designBlinded, multicenter, cross-sectional study.

settingCommunities surrounding 22 participating academic and regional health care systems in the United States.

participants4482 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.

resultsSensitivity 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.

conclusionStool 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.

Indexed as

Occult BloodAdenocarcinomaAdultColonoscopyColorectal NeoplasmsCross-Sectional StudiesDNA, NeoplasmEpidemiologic Research DesignFecesGenetic MarkersHumansMiddle AgedProspective StudiesSensitivity and SpecificityDNA, NeoplasmGenetic Markers

Identifiers

PMID18838724
PMCPMC4016975
OpenAlexW2115888302

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.