NCT01435590

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

September 13, 2011

Last Update Submit

May 27, 2015

Conditions

Cervical Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Specimen adequacy

    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).

    09/2011 - 05/2012 (1 year)

Secondary Outcomes (1)

  • Patient discomfort

    09/2011 to 05/2012 (8 months)

Interventions

Curette v/s endocervical brushPROCEDURE

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Absence of uterus
  • History of DES exposure in utero

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Undurraga M, Catarino R, Navarria I, Ibrahim Y, Puget E, Royannez Drevard I, Pache JC, Tille JC, Petignat P. User perception of endocervical sampling: A randomized comparison of endocervical evaluation with the curette vs cytobrush. PLoS One. 2017 Nov 6;12(11):e0186812. doi: 10.1371/journal.pone.0186812. eCollection 2017.

    PMID: 29107949DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medecin Interne

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 16, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05