New Technologies for Cervical Cancer screening

Conditions

Cervical cancer Cancer Cervical cancer

Carozzi F, Carozzi F, Gillio-Tos A, Confortini M, Del Mistro A, Sani C, De Marco L, Girlando S, Rosso S, Naldoni C, Dalla Palma P, Zorzi M, Giorgi-Rossi P, Segnan N, Cuzick J, Ronco G, NTCC working group.

2012-12-21108 citations

10.1016/s1470-2045(12)70529-6

Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial.

Ronco G, Giorgi-Rossi P, Carozzi F, Carozzi F, Confortini M, Dalla Palma P, Del Mistro A, Ghiringhello B, Girlando S, Gillio-Tos A, De Marco L, Naldoni C, Pierotti P, Rizzolo R, Schincaglia P, Zorzi M, Zappa M, Segnan N, Cuzick J, New Technologies for Cervical Cancer screening (NTCC) Working Group.

2010-01-18638 citations

10.1016/s1470-2045(09)70360-2

Use of p16-INK4A overexpression to increase the specificity of human papillomavirus testing: a nested substudy of the NTCC randomised controlled trial.

Carozzi F, Carozzi F, Confortini M, Dalla Palma P, Del Mistro A, Gillio-Tos A, De Marco L, Giorgi-Rossi P, Pontenani G, Rosso S, Sani C, Sintoni C, Segnan N, Zorzi M, Cuzick J, Rizzolo R, Ronco G, New Technologies for Cervival Cancer Screening (NTCC) Working Group.

2008-09-08142 citations

10.1016/s1470-2045(08)70208-0

The risk of false-positive histology according to the reason for colposcopy referral in cervical cancer screening: a blind revision of all histologic lesions found in the NTCC trial.

Dalla Palma P, Giorgi Rossi P, Collina G, Buccoliero AM, Ghiringhello B, Lestani M, Onnis G, Aldovini D, Galanti G, Casadei G, Aldi M, Gomes V, Giubilato P, Ronco G, NTCC Pathology Group.

2008-01-0135 citations

10.1309/ewygwfrrm8798u5p

The impact of new technologies in cervical cancer screening: results of the recruitment phase of a large randomised controlled trial from a public health perspective.

Giorgi-Rossi P, Segnan N, Zappa M, Naldoni C, Zorzi M, Confortini M, Merito M, Cuzick J, Ronco G, NTCC Working Group.

2007-12-019 citations

10.1002/ijc.23055

Accuracy of liquid based versus conventional cytology: overall results of new technologies for cervical cancer screening: randomised controlled trial.

Ronco G, Cuzick J, Pierotti P, Cariaggi MP, Dalla Palma P, Naldoni C, Ghiringhello B, Giorgi-Rossi P, Minucci D, Parisio F, Pojer A, Schiboni ML, Sintoni C, Zorzi M, Segnan N, Confortini M.

2007-05-21147 citations

10.1136/bmj.39196.740995.be

Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial.

Ronco G, Giorgi-Rossi P, Carozzi F, Carozzi F, Dalla Palma P, Del Mistro A, De Marco L, De Lillo M, Naldoni C, Pierotti P, Rizzolo R, Segnan N, Schincaglia P, Zorzi M, Confortini M, Cuzick J, New Technologies for Cervical Cancer screening Working Group.

2006-07-01157 citations

10.1016/s1470-2045(06)70731-8

Interventions

Women in conventional arm have conventional cytology and are referred for colposcopy according to the standard regular protocols. Experimental arm follows two phases: In phase 1, women have both liqu

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women 25 to 60 years old coming for a new screening episode in nine organised cervical screening programmes

Exclusion criteria

Exclusion criteria: 1. Virgin 2. Pregnant 3. Hysterectomised 4. Treated for cervical cancer or intraepithelial lesions in last five years

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the detection rate (DR) of histologically confirmed cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). In order to test the study hypothesis we will consider DR of CIN2+ after recruitment and up to including re-screening among women who tested negative at recruitment. The DR of CIN2+ at recruitment will be studied in order to investigate the cross sectional sensitivity of new technologies compared to conventional cytology (hypothesis: higher DR in experimental arm). The overall DR at recruitment and up to including re-screening in the two arms will be compared in order to study the relative over-diagnosis of regressive lesions.	—

Measure

Time frame

The primary outcome measure is the detection rate (DR) of histologically confirmed cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). In order to test the study hypothesis we will consider DR of CIN2+ after recruitment and up to including re-screening among women who tested negative at recruitment. The DR of CIN2+ at recruitment will be studied in order to investigate the cross sectional sensitivity of new technologies compared to conventional cytology (hypothesis: higher DR in experimental arm). The overall DR at recruitment and up to including re-screening in the two arms will be compared in order to study the relative over-diagnosis of regressive lesions.

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Secondary

Measure	Time frame
Main secondary outcome measures are the referral rate to colposcopy and the positive predictive value for CIN2+ in the two study arms.	—

Countries

Italy

Outcome results

None listed