Evidence map›Paper›PMID 21471141›Full record

Trial reportSexually transmitted infections2011

Chlamydia trachomatis infection and risk of cervical intraepithelial neoplasia.

Matti Lehtinen, Kevin A Ault, Erika Lyytikainen, Joakim Dillner, Suzanne M Garland, Daron G Ferris, Laura A Koutsky, Heather L Sings, Shuang Lu, Richard M Haupt and 2 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Sexually transmitted infections, 2011. 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 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00092521 phase3completednot on this map

A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2001 to 2009Enrolled5,759ConditionsCervical Cancer, Genital WartsArmsV501, Comparator: Placebo, Human Papillomavirus (HPV) 16 Monovalent
NCT00092534 phase3completednot on this map

A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2002 to 2025Enrolled12,167ConditionsCervical Cancer, Genital WartsArmsGardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine, Matching Placebo
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Bacterial-Mediated Tumor Therapy: Old Treatment in a New Context.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023
    Review
  7. Review
  8. Epidemiology and infection · 2022
    Article
  9. Association ofBMJ open · 2022
    Article
  10. Iranian journal of public health · 2022
    Review
  11. Review
  12. Review
  13. Article
  14. Journal of Cancer · 2021
    Review
  15. Article
  16. Review
  17. Microbes in Tumoral In Situ Tissues and in Tumorigenesis.Frontiers in cellular and infection microbiology · 2020
    Review
  18. Article
  19. Review
  20. The Prevalence of HSV, HHV-6, HPV andPathogens (Basel, Switzerland) · 2019
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Matti LehtinenSchool of Health Sciences, University of Tampere, Tampere 33014, Finland. llmale@uta.fi
Kevin A Ault
Erika Lyytikainen
Joakim Dillner
Suzanne M Garland
Daron G Ferris
Laura A Koutsky
Heather L Sings
Shuang Lu
Richard M Haupt
Jorma Paavonen
FUTURE I and II Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesHigh-risk human papillomavirus (hrHPV) is the primary cause of cervical cancer. As Chlamydia trachomatis is also linked to cervical cancer, its role as a potential co-factor in the development of cervical intraepithelial neoplasia (CIN) grade 2 or higher was examined.

methodsThe placebo arms of two large, multinational, clinical trials of an HPV6/11/16/18 vaccine were combined. A total of 8441 healthy women aged 15-26 years underwent cervicovaginal cytology (Papanicolaou (Pap) testing) sampling and C trachomatis testing at day 1 and every 12 months thereafter for up to 4 years. Protocol-specified guidelines were used to triage participants with Pap abnormalities to colposcopy and definitive therapy. The main outcome measured was CIN.

resultsAt baseline, 2629 (31.1%) tested positive for hrHPV DNA and 354 (4.2%) tested positive for C trachomatis. Among those with HPV16/18 infection (n = 965; 11.4%) or without HPV16/18 infection (n = 7382, 87.5%), the hazard ratios (HRs) associated with development of any CIN grade 2 according to baseline C trachomatis status were 1.82 (95% CI: 1.06 to 3.14) and 1.74 (95% CI 1.05 to 2.90), respectively. The results were comparable when only the 12 most common hrHPV infections were considered, but the excess risk disappeared when the outcome was expanded to include CIN grade 3 or worse.

conclusionFurther studies based on larger cohorts with longitudinal follow-up in relation to the C trachomatis acquisition and a thorough evaluation of temporal relationships of infections with hrHPV types, C trachomatis and cervical neoplasia are needed to demonstrate whether and how in some situations C trachomatis sets the stage for cervical carcinogenesis. Trial registration NCT00092521 and NCT00092534.

Indexed as

AdolescentAdultChlamydia InfectionsCoitusDisease ProgressionDNA, ViralEarly Detection of CancerFemaleHumansPapillomaviridaePapillomavirus InfectionsRisk FactorsSexual PartnersUterine Cervical DysplasiaUterine Cervical NeoplasmsYoung AdultDNA, Viral

Identifiers

PMID21471141
PMCPMC3252607

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.