Evidence map›Paper›PMID 32807113›Full record

ArticleBMC cancer2020

The efficacy of a leukotriene receptor antagonist in the treatment of human rectal aberrant crypt foci: a nonrandomized, open-label, controlled trial.

Takuma Higurashi, Jun Arimoto, Keiichi Ashikari, Tomohiro Takatsu, Noboru Misawa, Tsutomu Yoshihara, Tetsuya Matsuura, Akiko Fuyuki, Hidenori Ohkubo, Atsushi Nakajima

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 47% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Review
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

10 authors at 1 institution in 1 country.

Takuma HigurashiDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan. takuma_h@yokohama-cu.ac.jp.ORCID http://orcid.org/0000-0002-1815-4396
Jun ArimotoDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Keiichi AshikariDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Tomohiro TakatsuDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Noboru MisawaDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Tsutomu YoshiharaDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Tetsuya MatsuuraDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Akiko FuyukiDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Hidenori OhkuboDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Atsushi NakajimaDepartment of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.
Yokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeukotriene receptor antagonists (LTRAs) are broadly used for the management of allergic asthma and have recently been indicated to inhibit carcinogenesis and cancer cell growth. In colorectal cancer (CRC) chemoprevention studies, the occurrence of adenoma or CRC itself is generally set as the trial endpoint. Although the occurrence rate of CRC is the most confident endpoint, it is inappropriate for chemoprevention studies because CRC incidence rate is low in the general population and needed for long-term monitoring. Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and darker in methylene blue staining than normal crypts, are regarded to be a fine surrogate biomarker of CRC. Therefore, this prospective study was designed to explore the chemopreventive effect of LTRA on colonic ACF formation and the safety of the medicine in patients scheduled for a poly resection as a pilot trial leading the CRC chemoprevention trial.

methodsThis study is a nonrandomized, open-label, controlled trial in patients with colorectal ACF and polyps scheduled for a polypectomy. Participants meet the inclusion criteria will be recruited, and the number of ACF in the rectum will be counted at the baseline colonoscopic examination. Next, the participants will be assigned to the LTRA or no treatment group. Participants in the LTRA group will continue 10 mg of oral montelukast for 8 weeks, and those in the no treatment group will be observed without the administration of any additional drugs. At the end of the 8-week LTRA intervention period, a polypectomy will be conducted to evaluate the changes in the number of ACF, and cell proliferation in the normal colorectal epithelium will be analyzed. DISCUSSION: This will be the first study to investigate the effect of LTRAs on colorectal ACF formation in humans.

trial registrationThis trial has been registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000029926 . Registered 10 November 2017.

Indexed as

Aberrant Crypt FociAcetatesAdministration, OralAdultAgedAged, 80 and overBiopsyCell ProliferationColonColonic PolypsColonoscopyControlled Clinical Trials as TopicCyclopropanesFemaleHumansIntestinal MucosaAcetatesCyclopropanesLeukotriene AntagonistsmontelukastQuinolinesSulfidesAberrant crypt fociChemopreventionColorectal CancerLeukotriene receptor antagonist

Identifiers

PMID32807113
PMCPMC7433177
OpenAlexW3049489497

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.