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

Cervical Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04000477
• Other study ID #: 2017_85
• Secondary ID: 2018-A03087-48
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: March 2023

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: Sophie Jonard, MD,PhD
• Phone: 0320446309
• Email: sophie.jonard[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 588
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Pathological Screening Smear
• Uterine Cervical Neoplasms

Intervention

Device:
• Cytobrush
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
• Kevorkian curette
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of sampling failures	Unsatisfactory sampling will be defined by a specimen containing <20 endocervical cells, <3 epithelial flaps, and one specimen without stroma.	once time, Baseline
Secondary	Pain Assessment Using a Visual Analogue Scale (VAS)		once time, Baseline