Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Manuela Undurraga Malinverno, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01435590
First received: September 13, 2011
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to diagnostic and patient discomfort.

METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC) or and endocervical brush. All samples will be submitted for histological study.


Condition Intervention
Cervical Dysplasia
Procedure: Curette v/s endocervical brush

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Specimen adequacy [ Time Frame: 09/2011 - 05/2012 (1 year) ] [ Designated as safety issue: No ]
    Cytological and histological interpretation of the endocervical brush specimens will then be performed, while for the endocervical currete specimens only histological interpretation will be done. The adequacy of the specimens will be based on the quantity of endocervical cells present (< or ≥ 20 endocervical cells), the quantity of histological material (< or ≥ 3 epithelial stripes) and the quality of histological material (absence or presence of lamina propia).


Secondary Outcome Measures:
  • Patient discomfort [ Time Frame: 09/2011 to 05/2012 (8 months) ] [ Designated as safety issue: No ]
    To evaluate the degree of patient discomfort, patients will be requested to complete a questionnaire once the exam has been completed. The main acceptance variables will be degree of helplessness, pain (on visual analog scales), willingness to undergo the test again, and overall satisfaction. Once the exam has been completed, the doctor performing the sampling will answer a questionnaire indicating his/her perception of the exam (patient's pain, technical difficulty performing the exam, doctors acceptability of the exam).


Estimated Enrollment: 180
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • French-speaking
  • 21 years or older
  • Attending our colposcopy clinic
  • Need for endocervical evaluation
  • Full autonomy or capacity to understand the procedures

Exclusion Criteria:

  • Pregnancy
  • Absence of uterus
  • History of DES exposure in utero
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Manuela Undurraga Malinverno, Medecin Interne, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01435590     History of Changes
Other Study ID Numbers: CER 11-029
Study First Received: September 13, 2011
Last Updated: September 15, 2011
Health Authority: Switzerland: Federal Office of Public Health

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 24, 2014