Evidence map›Paper›PMID 20798393›Full record

Trial reportJournal of the National Cancer Institute2010

Ornithine decarboxylase-1 polymorphism, chemoprevention with eflornithine and sulindac, and outcomes among colorectal adenoma patients.

Jason A Zell, Christine E McLaren, Wen-Pin Chen, Patricia A Thompson, Eugene W Gerner, Frank L Meyskens

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  5. Dietary polyamine intake and risk of colorectal adenomatous polyps.The American journal of clinical nutrition · 2012
    Trial
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  7. Trial
  8. Review
  9. Chemopreventive strategies for sporadic colorectal cancer: a narrative review.Translational gastroenterology and hepatology · 2025
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Jason A ZellChao Family Comprehensive Cancer Center, Department of Epidemiology, University of California Irvine, 224 Irvine Hall, Irvine, CA 92697, USA. jzell@uci.edu
Christine E McLaren
Wen-Pin Chen
Patricia A Thompson
Eugene W Gerner
Frank L Meyskens
University of California, Irvine · US

Funding

VITAMIN AP30CA023074 · NCI · UNIVERSITY OF ARIZONA · PI Dan Theodorescu · 1985 to 2026
$110.2M
Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Christine Hui · 1994 to 2026
$57.9M
SPORE in Gastrointestinal CancerP50CA095060 · NCI · UNIVERSITY OF ARIZONA · PI GERNER, EUGENE W · 2002 to 2012
$25.3M
Phase III Colon Cancer Prevention TrialR01CA088078 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI MEYSKENS, FRANK L. · 2002 to 2006
$4.2M
Prevention of APC-Dependent Intestinal CarcinogenesisR01CA123065 · NCI · UNIVERSITY OF ARIZONA · PI GERNER, EUGENE W · 2007 to 2011
$1.6M
PHASE II CLINICAL TRIAL OF DFMO &NSAID IN COLONN01CN075019 · CN · UNIVERSITY OF CALIFORNIA-IRVINE · PI MEYSKENS, FRANK L. · 1997 to 2006
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POLYAMINE DEPLETION AND CHEMOPREVENTION OF COLON CANCERR01CA059024 · NCI · UNIVERSITY OF CALIFORNIA IRVINE · PI MEYSKENS, FRANK LOUIS · 1993 to 1996
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NCI NIH HHS CA23074NCI NIH HHS CA59024NCI NIH HHS CA88078NCI NIH HHS CA95060NCI NIH HHS N01-CN75019NCI NIH HHS P30 CA023074NCI NIH HHS P30 CA062203NCI NIH HHS P30 CA62230NCI NIH HHS P50 CA095060NCI NIH HHS R01 CA059024NCI NIH HHS R01 CA088078NCI NIH HHS R01 CA123065
6 · The paper itself

Abstract

The ornithine decarboxylase-1 (ODC1) polymorphism at position +316 affects binding by transcriptional activators and repressors and modulates the risk of metachronous colorectal adenomas, particularly in association with aspirin use. We investigated the effects of ODC1 after treatment with difluoromethylornithine (eflornithine)/sulindac or placebo. Two hundred twenty-eight colorectal adenoma patients in a randomized phase III trial were genotyped for ODC1. We used Wilcoxon rank sums tests on non-normally distributed continuous variables across two genotype groups, χ(2) or Fisher exact test to assess the association between baseline categorical variables and genotype group, and log binomial regression for the primary (adenoma recurrence) and secondary outcomes (tissue polyamine response, cardiovascular toxicity, gastrointestinal toxicity, and ototoxicity). All statistical tests were two-sided. In binomial regression models with variables age, sex, race, aspirin use, treatment, and ODC1 genotype, treatment was the only statistically significant factor associated with differences in adenoma recurrence or tissue polyamine response. A statistically significant interaction was detected between ODC1 genotype and treatment with respect to adenoma recurrence (placebo group: GG, 50%, AA/GA: 34%; treatment group: GG, 11%, AA/GA, 21%; P(interaction) = .038). Excess ototoxicity was observed among ODC1 AA patients receiving treatment, but the interaction of genotype and treatment on ototoxicity was not statistically significant (P = .45).

Indexed as

Polymorphism, Single NucleotideAdenomaAgedAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsConfounding Factors, EpidemiologicEflornithineEnzyme InhibitorsFemaleGene FrequencyGenotypeHumansMaleMiddle AgedProteinsSulindacEflornithineEnzyme Inhibitorsornithine decarboxylase antizymeProteinsSulindac

Identifiers

PMID20798393
PMCPMC2950167
OpenAlexW2107789601

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.