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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

September 13, 2011
September 15, 2011
September 2011
May 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01435590 on ClinicalTrials.gov Archive Site
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).
Same as current
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Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
Not Provided

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Cervical Dysplasia
Procedure: Curette v/s endocervical brush
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
180
September 2012
May 2012   (final data collection date for primary outcome measure)

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
Female
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01435590
CER 11-029
No
Manuela Undurraga Malinverno, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Not Provided
University Hospital, Geneva
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP