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Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear (ENDOCOL)

Primary Purpose

Cervical Cancer, Pathological Screening Smear

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cytobrush
Kevorkian curette
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring Endocervical curettage, Kevorkian, Cytobrush, FCV

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women followed for a cervical pathology requiring endocervical curettage:
  • AGC type (glandular cell atypia) with positive HPV test
  • Frottis ASC-H, LSIL, ASCUS HPV + with non-contributive colposcopy (ZT3)

Exclusion Criteria:

  • Pregnant woman
  • Women under the age of 25 or over 65
  • Stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material)
  • Presence of a vaginal lesion on colposcopic examination

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Kevorkian curette

    Cytobrush

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of sampling failures
    Unsatisfactory sampling will be defined by a specimen containing <20 endocervical cells, <3 epithelial flaps, and one specimen without stroma.

    Secondary Outcome Measures

    Pain Assessment Using a Visual Analogue Scale (VAS)

    Full Information

    First Posted
    June 26, 2019
    Last Updated
    November 19, 2020
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04000477
    Brief Title
    Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear
    Acronym
    ENDOCOL
    Official Title
    Endocervical Curettage Performed With a Kevorkian Curette Versus Cytobrush in Patients With ASC-H, LSIL, ASCUS HPV Positive and Non-contributory Colposcopy (ZT3) Smear or Atypical Pap Smear With Positive HPV Test
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The recommendations on the method and the realization of the cervico-uterine smears are clear. With regard to performing endocervical curettage, several methods are possible without precise consensus. In general, the Kevorkian curette is widely used. However, it is often reported by doctors and patients that curettage is painful. Some articles show that the cytobrush would be less painful. While keeping a percentage of correct curettage failures, it is sought to show that the cytobrush would improve the comfort of the patient during curettage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Pathological Screening Smear
    Keywords
    Endocervical curettage, Kevorkian, Cytobrush, FCV

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    588 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Kevorkian curette
    Arm Type
    Experimental
    Arm Title
    Cytobrush
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Cytobrush
    Intervention Description
    the brush would be inserted in full until the display of the brush in the endocervical canal disappears. A neck quadrant scan (= quarter turn) will be performed from front to back while simultaneously rotating the brush clockwise, for a total of 3 laps. This would represent 4 sweeps per turn, ie 12 sweeps in total
    Intervention Type
    Device
    Intervention Name(s)
    Kevorkian curette
    Intervention Description
    the colposcopist holds the curette horizontally and scrapes the endocervical canal all the way around. He realizes 1 small firm and linear movement by quarter turn or 4 movements to realize a complete turn. During this act, the curette must remain inside the canal, and during its extraction, care should be taken not to rotate it so as not to spill the collected tissue contained in the basket of the curette. The tissue material thus obtained must be rapidly immersed in formalin
    Primary Outcome Measure Information:
    Title
    Percentage of sampling failures
    Description
    Unsatisfactory sampling will be defined by a specimen containing <20 endocervical cells, <3 epithelial flaps, and one specimen without stroma.
    Time Frame
    once time, Baseline
    Secondary Outcome Measure Information:
    Title
    Pain Assessment Using a Visual Analogue Scale (VAS)
    Time Frame
    once time, Baseline

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Patients aged 25 to 65 years old whose screening smear returned pathologically and who are therefore followed in colposcopy
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women followed for a cervical pathology requiring endocervical curettage: AGC type (glandular cell atypia) with positive HPV test Frottis ASC-H, LSIL, ASCUS HPV + with non-contributive colposcopy (ZT3) Exclusion Criteria: Pregnant woman Women under the age of 25 or over 65 Stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material) Presence of a vaginal lesion on colposcopic examination
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sophie Jonard, MD,PhD
    Phone
    0320446309
    Ext
    +33
    Email
    sophie.jonard@chru-lille.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sophie Jonard, MD,PhD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear

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