SHENZHEN CERVICAL CANCER SCREENING PROGRAM – II
Between April, 2009 and April, 2010, a multi-site, a 10,000 women population-based cross-sectional study (The Shenzhen Cervical Cancer Screening Trial II (SHENCCAST II) was carried out in seven sites in Guangdong Province China, to evaluate a new self-sampling device POI self sampler, a new cytology imaging system (I2 Imager), and two new HPV testing technologies (Cervista, MALDI-TOF [PCR based Mass Array Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight mass spectrometry system]) applied both to self-sampling as well as direct endocervical sampling. The women were recruited in the urban site (Shenzhen) through a mass media campaign. In the suburban sites (Longang and Bao’an) women were recruited either through government notification or through recruitment at local health clinics respectively (this included public notices and community meetings). In the rural sites (Wushi, Feng’an, Longwo, Heping) the women were all recruited by the local health clinics under government authority. Women were eligible if they were 25-59 years of age, not pregnant, had no cervical cancer screening for at least three years, no prior hysterectomy, and no prior pelvic radiation.
The Six papers have now been published . The first study, (Am J Clin Pathol 2011;135:790-795), demonstrates that the differences in accuracy in diagnosing ≥CIN 3 between HR-HPV testing with Cervista and with HC-II are minor and result from the decisions made in selecting their cut-points. The choice, as to which test a laboratory should choose, will come down to price, ease of use, and rate for specimen through-put. The second, a clinical paper concerning the application of a new multiplex HPV assay using MALDI-TOF, was paired with a methods paper (development of the assay) and the two were published in the Am. Journal of Clinical Pathology (2011 Dec;136(6)). A fourth manuscript was published (Int J Cancer. 2012, Apr. 15:130(8):1855-60) and definitely demonstrated methodology for self-collection that is as sensitive as a physician obtained sample. In addition the technology is applicable to population based screening with high through-put at a very low cost per case. A 5th manuscript on secondary screening after self-collection for HPV was published in the J Low Genit Tract Dis. 2012 Oct;16(4):416-20. The 6th manuscript uses data from SHENNCAST II and III (Triage of women with negative cytology and positive high-risk HPV: An analysis of data from the SHENCCAST II/III studies. J Low Genit Tract Dis. 2013 Nov 21 (epub ahead of print PMID: 24270196))
In addition the SHENCCAST II samples have contributed to the evaluation of the Cervista 16/18 assay (SHENCCAST III), the validation of the Incell Dx E6/E7 mRNA assay for HPV , and the development of a new hrHPV assay (by BGI Shenzhen) based on next generation genomic sequencing. (Project – SEQHPV)