Status:

COMPLETED

Conservative Management of CIN2 Lesions and Biomarkers Evaluation

Lead Sponsor:

Istituto Oncologico Veneto IRCCS

Collaborating Sponsors:

Azienda ULSS 3 Serenissima

Azienda Ulss 6 Euganea

Conditions:

CIN2

Eligibility:

FEMALE

25-45 years

Brief Summary

Prospective study including women aged 25-45 years, adherent to the cervical screening program of four different centers of the Veneto region, with a diagnosis of CIN2 lesion. After enrollment accordi...

Detailed Description

Women aged 25-45 years, adherent to the organized population-based cervical screening program, with a histological diagnosis of CIN2 and fulfilling the inclusion criteria will be invited to participat...

Eligibility Criteria

Inclusion

  • age range 25-45 years,
  • CIN2 lesions located in the exocervix and completely visible at colposcopy.

Exclusion

  • age \>45 years;
  • history of previous high-grade lesions;
  • squamo-columnar junction not completely visible (type 3);
  • cytology with suspect or indicative for invasive lesion;
  • lesions exclusively located in the endocervix;
  • lesions located in the exocervix but not completely visible;
  • pregnancy

Key Trial Info

Start Date :

April 15 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2022

Estimated Enrollment :

319 Patients enrolled

Trial Details

Trial ID

NCT04687267

Start Date

April 15 2019

End Date

December 31 2022

Last Update

September 28 2023

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Azienda ULSS 6 Euganea

Padua, PD, Italy

2

Azienda ULSS 2 Marca Trevigiana

Treviso, TV, Italy

3

Azienda ULSS 3 Serenissima

Mestre, VE, Italy

4

Azienda ULSS 9 Scaligera

Verona, VR, Italy