title: Pilot study of cytological testing for oesophageal squamous cell dysplasia in a high-risk area in Northern Iran.
abstract: BACKGROUND
  Oesophageal squamous cell carcinoma (ESCC) is a fatal disease with 5-year survival rates of <5% in Northern Iran. Oesophageal squamous dysplasia (ESD) is the precursor histologic lesion of ESCC. This pilot study was conducted to assess the feasibility, safety, and acceptability of non-endoscopic cytological examination of the oesophagus and to provide initial data on the accuracy of cytological atypia for identifying patients with ESD in this very-high-risk area.
  
  
  METHODS
  Randomly selected asymptomatic participants of the Golestan Cohort Study were recruited. A cytological specimen was taken using a capsule sponge device and evaluated for atypical cells. Sections of the cytological specimen were also stained for p53 protein. Patient acceptability was assessed using a visual analogue scale. The cytological diagnosis was compared with a chromoendoscopic examination using Lugol's solution.
  
  
  RESULTS
  Three hundred and forty-four subjects (43% male, mean (s.d.) age 55.6 (7.9) years) were referred to the study clinic. Three hundred and twelve met eligibility criteria and consented, of which 301 subjects (96.5%) completed both cytological and endoscopic examinations. There were no complications. Most of the participants (279; 92.7%) were satisfied with the examination. The sensitivity and specificity of the cytological examination for identifying subjects with high-grade ESD were 100 and 97%, respectively. We found an accuracy of 100% (95% CI=99-100%) for a combination of cytological examination and p53 staining to detect high-grade ESD.
  
  
  CONCLUSIONS
  The capsule sponge methodology seems to be a feasible, safe, and acceptable method for diagnosing precancerous lesions of the oesophagus in this population, with promising initial accuracy data for the detection of high-grade ESD.
authors.affiliation: 1] Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran [2] Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan 4917774979, Iran.
authors.forename: G
authors.initials: G
authors.lastname: Roshandel
authors.affiliation: Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran.
authors.forename: S
authors.initials: S
authors.lastname: Merat
authors.affiliation: Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Sotoudeh
authors.affiliation: Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan 4917774979, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Khoshnia
authors.affiliation: Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran.
authors.forename: H
authors.initials: H
authors.lastname: Poustchi
authors.affiliation: MRC Cancer Cell, Hutchison-MRC Research Centre, University of Cambridge, Cambridge CB2 0XZ, UK.
authors.forename: P
authors.initials: P
authors.lastname: Lao-Sirieix
authors.affiliation: MRC Cancer Cell, Hutchison-MRC Research Centre, University of Cambridge, Cambridge CB2 0XZ, UK.
authors.forename: S
authors.initials: S
authors.lastname: Malhotra
authors.affiliation: MRC Cancer Cell, Hutchison-MRC Research Centre, University of Cambridge, Cambridge CB2 0XZ, UK.
authors.forename: M
authors.initials: M
authors.lastname: O'Donovan
authors.affiliation: 1] Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran [2] Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD 20895, USA.
authors.forename: A
authors.initials: A
authors.lastname: Etemadi
authors.affiliation: Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Nickmanesh
authors.affiliation: Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Pourshams
authors.affiliation: Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan 4917774979, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Norouzi
authors.affiliation: MRC Cancer Cell, Hutchison-MRC Research Centre, University of Cambridge, Cambridge CB2 0XZ, UK.
authors.forename: I
authors.initials: I
authors.lastname: Debiram
authors.affiliation: Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan 4917774979, Iran.
authors.forename: S
authors.initials: S
authors.lastname: Semnani
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD 20895, USA.
authors.forename: C C
authors.initials: CC
authors.lastname: Abnet
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD 20895, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Dawsey
authors.affiliation: MRC Cancer Cell, Hutchison-MRC Research Centre, University of Cambridge, Cambridge CB2 0XZ, UK.
authors.forename: R C
authors.initials: RC
authors.lastname: Fitzgerald
authors.affiliation: Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran.
authors.forename: R
authors.initials: R
authors.lastname: Malekzadeh
mesh_terms: D002278:Carcinoma in Situ / Q000175:diagnosis / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000473:pathology; D015331:Cohort Studies; D004938:Esophageal Neoplasms / Q000175:diagnosis* / Q000473:pathology; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D006801:Humans; D007492:Iran; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011230:Precancerous Conditions / Q000175:diagnosis* / Q000473:pathology; D012307:Risk Factors