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

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ClinicalTrials.gov Identifier: NCT01435590
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Manuela Undurraga Malinverno, University Hospital, Geneva

Brief Summary:

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 or disease Intervention/treatment
Cervical Dysplasia Procedure: Curette v/s endocervical brush

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Study Start Date : September 2011
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Specimen adequacy [ Time Frame: 09/2011 - 05/2012 (1 year) ]
    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 :
  1. Patient discomfort [ Time Frame: 09/2011 to 05/2012 (8 months) ]
    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).

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manuela Undurraga Malinverno, Medecin Interne, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01435590     History of Changes
Other Study ID Numbers: CER 11-029
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

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