New Technologies for Cervical Cancer screening
| ISRCTN | ISRCTN81678807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81678807 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/04/2005
- Registration date
- 03/06/2005
- Last edited
- 03/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Guglielmo Ronco
Scientific
Scientific
Via San Francesco da Paola 31
Torino
10123
Italy
| Phone | +39 (0)116333850 |
|---|---|
| guglielmo.ronco@cpo.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| Scientific title | |
| Study acronym | NTCC |
| Study objectives | 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. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Cervical cancer |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | Main secondary outcome measures are the referral rate to colposcopy and the positive predictive value for CIN2+ in the two study arms. |
| Overall study start date | 01/02/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 94,000 |
| Key inclusion criteria | Women 25 to 60 years old coming for a new screening episode in nine organised cervical screening programmes |
| Key exclusion criteria | 1. Virgin 2. Pregnant 3. Hysterectomised 4. Treated for cervical cancer or intraepithelial lesions in last five years |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via San Francesco da Paola 31
Torino
10123
Italy
10123
Italy
Sponsor information
CPO Piemonte (Italy)
Government
Government
Via San Francesco da Paola 31
Torino
10123
Italy
"ROR" |
https://ror.org/05v0e5774 |
|---|
Funders
Funder type
Government
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"
No information available
European Union (Belgium) - Europe Against Cancer contracts SI2.327046 and SPC.2002475
No information available
Regional Administrations of the Italian Regions involved (Piemonte, Veneto, Emilia-Romagna, Toscana, Lazio and Provncia Autonoma di Trento)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2006 | Yes | No | |
| Results article | results | 07/07/2007 | Yes | No | |
| Results article | results of blind revision of historic lesions | 01/01/2008 | Yes | No | |
| Results article | results | 01/03/2010 | Yes | No | |
| Results article | age-specific patterns of unsatisfactory results | 01/08/2010 | Yes | No | |
| Results article | results | 01/08/2010 | Yes | No | |
| Results article | results of nested substudy | 01/02/2013 | Yes | No |
