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A phase II clinical study to assess the feasibility of self and partner anal examinations to detect anal canal abnormalities including anal cancer
  1. Alan G Nyitray1,
  2. Joseph T Hicks1,
  3. Lu-Yu Hwang1,
  4. Sarah Baraniuk2,
  5. Margaret White3,
  6. Stefanos Millas4,
  7. Nkechi Onwuka5,
  8. Xiaotao Zhang5,
  9. Eric L Brown1,
  10. Michael W Ross6,
  11. Elizabeth Y Chiao7
  1. 1Department of Epidemiology, Human Genetics and Environmental Sciences, Center for Infectious Diseases, The University of Texas Health Science Center School of Public Health at Houston, Houston, TX, USA
  2. 2Department of Biostatistics, Coordinating Center for Clinical Trials, The University of Texas Health Science Center School of Public Health at Houston, Houston, Texas, USA
  3. 3Gordon Crofoot MD PA, Houston, USA
  4. 4Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA
  5. 5Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas Health Science Center School of Public Health at Houston, Houston, Texas, USA
  6. 6University of Minnesota, Program in Human Sexuality, Minneapolis, Minnesota, USA
  7. 7Department of Internal Medicine, Baylor College of Medicine, Houston, Texas, USA
  1. Correspondence to Dr Alan G Nyitray, Center for Infectious Diseases, Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas Health Science Center School of Public Health at Houston, 1200 Pressler St., RAS E707, Houston, Texas 77030, USA; alan.g.nyitray{at}uth.tmc.edu

Abstract

Objective Anal cancer is a common cancer among men who have sex with men (MSM); however, there is no standard screening protocol for anal cancer. We conducted a phase II clinical trial to assess the feasibility of teaching MSM to recognise palpable masses in the anal canal which is a common sign of anal cancer in men.

Methods A clinician skilled in performing digital anorectal examinations (DARE) used a pelvic manikin to train 200 MSM, aged 27–78 years, how to do a self-anal examination (SAE) for singles or a partner anal examination (PAE) for couples. The clinician then performed a DARE without immediately disclosing results, after which the man or couple performed an SAE or PAE, respectively. Percentage agreement with the clinician DARE in addition to sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for the SAE, PAE and overall.

Results Men had a median age of 52 years, 42.5% were African American and 60.5% were HIV positive. DARE detected abnormalities in 12 men while the men’s SAE/PAEs detected 9 of these. A total of 93.0% of men classified the health of their anal canal correctly (95% CI 89.5 to 96.5). Overall percentage agreement, sensitivity and specificity were 93.0%, 75.0% and 94.2%, respectively, while PPV and NPV were 45.0% and 98.3%, respectively. The six men who detected the abnormality had nodules/masses ≥3 mm in size. More than half of men (60.5%) reported never checking their anus for an abnormality; however, after performing an SAE/PAE, 93.0% said they would repeat it in the future.

Conclusion These results suggest that tumours of ≥3 mm may be detectable by self or partner palpation among MSM and encourage further investigation given literature suggesting a high cure rate for anal cancer tumours ≤10 mm.

  • digital rectal examination
  • HIV
  • anal canal
  • anus neoplasms
  • homosexuality
  • male
  • early detection of cancer

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Footnotes

  • Handling editor Joseph D Tucker

  • Contributors AGN, L-YH, MWR and EYC conceptualised the study and formulated the hypotheses. AGN, JTH, NO, MW and SM conducted the investigation. AGN, XZ and SB did the statistical analysis. XZ provided data curation. AGN was responsible for funding acquisition, determining methodology and writing the paper. JTH, L-YH, SB, MW, SM, NO, XZ, ELB, MWR and EYC critically reviewed and edited subsequent drafts.

  • Funding This work was supported by the National Cancer Institute at the National Institutes of Health [grant number NCI 1R21CA181901-02) to AGN; ClinicalTrials.gov number, NCI-2015-00248]. Publication and report contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCI.

  • Competing interests The institutions of AGN, JTH, and EYC received NIH grants or subcontracts for the submitted works and/or grants from the NIH outside of the submitted work.

  • Ethics approval University of Texas Health Sciences Center Committee for the Protection of Human Subjects.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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