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New Technologies for Cervical Cancer screening
ISRCTN ISRCTN81678807
DOI 10.1186/ISRCTN81678807
ClinicalTrials.gov identifier
EudraCT number
Public title New Technologies for Cervical Cancer screening
Scientific title
Acronym NTCC
Serial number at source N/A
Study hypothesis Women who test negative in the experimental arm have a lower risk than women who test negative in the conventional arm of having a high-grade pre-invasive lesion detected in the three years following screening, therefore allowing longer screening intervals.
Lay summary Not provided at time of registration
Ethics approval The NTCC study was approved by the local research ethics committees of the participating centres. Ethical approval was obtained by the Dutch Ministry of Health, Welfare, and Sport for the NETHCON trial
Study design Randomised controlled trial
Countries of recruitment Italy
Disease/condition/study domain Cervical cancer
Participants - inclusion criteria Women 25 to 60 years old coming for a new screening episode in nine organised cervical screening programmes
Participants - exclusion criteria 1. Virgin
2. Pregnant
3. Hysterectomised
4. Treated for cervical cancer or intraepithelial lesions in last five years
Anticipated start date 01/02/2002
Anticipated end date 31/12/2004
Status of trial Completed
Patient information material
Target number of participants 94,000
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 liquid based cytology and human papillomavirus (HPV) testing (by Hybrid Capture 2) for high risk types. Women aged 35 years or more are referred for colposcopy if either HPV is positive or cytology is atypical cells of undetermined significance (ASCUS) or more severe. Women of age less than 35 are directly referred for colposcopy if cytology is ASCUS or more severe. If HPV is positive but cytology is less than ASCUS women are invited for repeating both tests after one year and referred for cytology if either is positive.

In phase 2, women in the experimental arm are tested only for HPV and are referred for colposocpy if it is positive, independently of age.

Women in both arms are be recalled for new screening by conventional cytology after three years. The detection of CIN2+ after recruitment and up to re-screening included will be compared.
Primary outcome measure(s) 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.
Secondary outcome measure(s) Main secondary outcome measures are the referral rate to colposcopy and the positive predictive value for CIN2+ in the two study arms.
Sources of funding 1. Italian Ministry of Health (Italy) - progetto speciale "Valutazione di nuove tecnologie per lo screening del cervicocarcinoma" and progetto speciale "Nuove tecnologie per lo screening del cervicocarcinoma. Follow-up"
2. European Union (Belgium) - Europe Against Cancer contracts SI2.327046 and SPC.2002475
3. Regional Administrations of the Italian Regions involved (Piemonte, Veneto, Emilia-Romagna, Toscana, Lazio and Provncia Autonoma di Trento)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16814206
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17517761
3. 2008 results of blind revision of historic lesions in http://www.ncbi.nlm.nih.gov/pubmed/18089491
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20604775
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20089449
5. 2010 age-specific patterns of unsatisfactory results in http://www.ncbi.nlm.nih.gov/pubmed/20604775
6. 2013 results of nested substudy in http://www.ncbi.nlm.nih.gov/pubmed/23261355
Contact name Dr  Guglielmo  Ronco
  Address Via San Francesco da Paola 31
  City/town Torino
  Zip/Postcode 10123
  Country Italy
  Tel +39 (0)116333850
  Fax +39 (0)116333861
  Email guglielmo.ronco@cpo.it
Sponsor CPO Piemonte (Italy)
  Address Via San Francesco da Paola 31
  City/town Torino
  Zip/Postcode 10123
  Country Italy
Date applied 29/04/2005
Last edited 03/04/2013
Date ISRCTN assigned 03/06/2005
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