Evidence map›Paper›PMID 26503631›Full record

Trial reportGut2017

Spectral biomarkers for chemoprevention of colonic neoplasia: a placebo-controlled double-blinded trial with aspirin.

Hemant K Roy, Vladimir Turzhitsky, Ramesh Wali, Andrew J Radosevich, Borko Jovanovic, Gary Della'Zanna, Asad Umar, David T Rubin, Michael J Goldberg, Laura Bianchi and 12 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00468910 (Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 10% 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.

NCT00468910 phase2completednot on this map

Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2007 to 2011Enrolled79ConditionsColon Cancer, Precancerous Condition, Rectal CancerArmsacetylsalicylic acid, placebo, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
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  15. Elimination of CD4Cell research · 2018
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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

22 authors at 6 institutions in 1 country.

Hemant K RoyDepartment of Medicine, Boston University Medical Center, Boston, Massachusetts, USA.
Vladimir TurzhitskyDepartment of Biomedical Engineering, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Ramesh WaliDepartment of Medicine, Boston University Medical Center, Boston, Massachusetts, USA.
Andrew J RadosevichDepartment of Biomedical Engineering, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Borko JovanovicDepartment of Preventive Medicine, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Gary Della'ZannaDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.
Asad UmarDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.
David T RubinDepartment of Medicine, The University of Chicago Medical Center, Chicago, Illinois, USA.
Michael J GoldbergDepartment of Medicine, NorthShore University Health Systems, Evanston, Illinois, USA.
Laura BianchiDepartment of Medicine, NorthShore University Health Systems, Evanston, Illinois, USA.
Mart De La CruzDepartment of Medicine, Boston University Medical Center, Boston, Massachusetts, USA.
Andrej BogojevicDepartment of Medicine, NorthShore University Health Systems, Evanston, Illinois, USA.
Irene B HelenowskiDepartment of Preventive Medicine, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Luz RodriguezDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.
Robert ChattertonDepartment of Obstetrics and Gynecology, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Silvia SkripkauskasDepartment of Medicine, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Katherine PageDepartment of Medicine, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Christopher R WeberDepartment of Pathology, The University of Chicago Medical Center, Chicago, Illinois, USA.
Xiaoke HuangDepartment of Medicine, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Ellen RichmondDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.
Raymond C BerganDepartment of Medicine, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Vadim BackmanDepartment of Biomedical Engineering, Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, USA.
Northwestern University · USNational Cancer Institute · USNorthShore University HealthSystem · USBoston University · USUniversity of Chicago Medical Center · USBoston Medical Center · US

Funding

Tumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LEONIDAS C. PLATANIAS · 1993 to 2026
$153.9M
Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Community Clinical Oncology Program: FL Pediatric CCOPU10CA035157 · NCI · FLORIDA ASSN OF PEDIATRIC TUMOR PROG · PI TALBERT, JAMES L · 1985 to 2014
$5.0M
PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-261035157N01CN035157 · CN · NORTHWESTERN UNIVERSITY · PI BERGAN, RAYMOND C · 2004 to 2006
–
NCATS NIH HHS UL1 TR001422NCI NIH HHS N01 CN035157NCI NIH HHS P30 CA060553
6 · The paper itself

Abstract

objectiveA major impediment to translating chemoprevention to clinical practice has been lack of intermediate biomarkers. We previously reported that rectal interrogation with low-coherence enhanced backscattering spectroscopy (LEBS) detected microarchitectural manifestations of field carcinogenesis. We now wanted to ascertain if reversion of two LEBS markers spectral slope (SPEC) and fractal dimension (FRAC) could serve as a marker for chemopreventive efficacy.

designWe conducted a multicentre, prospective, randomised, double-blind placebo-controlled, clinical trial in subjects with a history of colonic neoplasia who manifested altered SPEC/FRAC in histologically normal colonic mucosa. Subjects (n=79) were randomised to 325 mg aspirin or placebo. The primary endpoint changed in FRAC and SPEC spectral markers after 3 months. Mucosal levels of prostaglandin E2 (PGE2) and UDP-glucuronosyltransferase (UGT)1A6 genotypes were planned secondary endpoints.

resultsAt 3 months, the aspirin group manifested alterations in SPEC (48.9%, p=0.055) and FRAC (55.4%, p=0.200) with the direction towards non-neoplastic status. As a measure of aspirin's pharmacological efficacy, we assessed changes in rectal PGE2 levels and noted that it correlated with SPEC and FRAC alterations (R=-0.55, p=0.01 and R=0.57, p=0.009, respectively) whereas there was no significant correlation in placebo specimens. While UGT1A6 subgroup analysis did not achieve statistical significance, the changes in SPEC and FRAC to a less neoplastic direction occurred only in the variant consonant with epidemiological evidence of chemoprevention.

conclusionsWe provide the first proof of concept, albeit somewhat underpowered, that spectral markers reversion mirrors antineoplastic efficacy providing a potential modality for titration of agent type/dose to optimise chemopreventive strategies in clinical practice. TRIAL NUMBER: NCT00468910.

Indexed as

AgedAnti-Inflammatory Agents, Non-SteroidalAspirinBiomarkers, TumorChemopreventionColonic NeoplasmsDinoprostoneDouble-Blind MethodFemaleGenotypeGlucuronosyltransferaseHumansIntestinal MucosaMaleMiddle AgedProspective StudiesAnti-Inflammatory Agents, Non-SteroidalAspirinBiomarkers, TumorDinoprostoneGlucuronosyltransferaseUDP-glucuronosyltransferase, UGT1A6COLORECTAL NEOPLASIA

Identifiers

PMID26503631
PMCPMC5108693
OpenAlexW1877133440

What OpenQuestion holds

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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.