Pilot study of cytological testing for oesophageal squamous cell dysplasia in a high-risk area in Northern Iran

• Published in: British journal of cancer Vol. 111; no. 12; pp. 2235 - 2241
• Main Authors: Roshandel, G, Merat, S, Sotoudeh, M, Khoshnia, M, Poustchi, H, Lao-Sirieix, P, Malhotra, S, O'Donovan, M, Etemadi, A, Nickmanesh, A, Pourshams, A, Norouzi, A, Debiram, I, Semnani, S, Abnet, C C, Dawsey, S M, Fitzgerald, R C, Malekzadeh, R
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 09.12.2014; Nature Publishing Group
• Subjects: 692/699/67/1504/1477; 692/699/67/2322; 692/699/67/2324; Accuracy; Asymptomatic; Biological and medical sciences; Biomarkers; Biomedical and Life Sciences; Biomedicine; Cancer; Cancer Research; Carcinoma in Situ - diagnosis; Carcinoma in Situ - pathology; Carcinoma, Squamous Cell - diagnosis; Carcinoma, Squamous Cell - pathology; Clinical Study; Cohort analysis; Cohort Studies; Disease; Drug Resistance; Endoscopy; Epidemiology; Esophageal Neoplasms - diagnosis; Esophageal Neoplasms - pathology; Esophageal Squamous Cell Carcinoma; Esophagus; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Iodine; Iran; Male; Medical research; Medical sciences; Methods; Middle Aged; Molecular Medicine; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Oncology; Pilot Projects; Precancerous Conditions - diagnosis; Precancerous Conditions - pathology; Risk Factors; Tumors; Iran; Asia; screening; oesophageal squamous cell carcinoma; cytological examination; Northern Iran; p53; High risk; Esophageal squamous dysplasia; Esophageal disease; Esophagus squamous cell carcinoma; Cytology; Malignant tumor; Medical screening; Esophagus cancer; Cancerology; TP53 Gene; Digestive diseases; Cell; Cancer; Tumor suppressor gene
• DOI: 10.1038/bjc.2014.506
• ISSN: 0007-0920; 1532-1827

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.