CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 288 enrolled
Drug / intervention
Endocervical liquid-base cytology +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05120167
NCT05120167N/ACompleted

Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology (ASC-H+) and Negative Colposcopy

Cirbia Silva Campos Teixeira·interventional·Posted Nov 15, 2021·Updated Jul 27, 2023

In Brief

A clinical study evaluating Endocervical liquid-base cytology, Endocervical cell block, and 1 other intervention for Diagnoses Disease and 3 related conditions. Completed, enrolled 288 participants across 4 sites.

Detailed Summary

cervical cancer is the fourth most frequent cancer in women worldwide and in Brazil, it occupies the third position for the triennium 2020/2022, with a high mortality rate and maintained in the last 10 years. It is associated with persistent human papillomavirus (HPV) infection. Primary prevention can be accomplished through vaccines that prevent HPV infection of the epithelial cells of the cervix. Secondary prevention in screening for precursor lesions through periodic repeat cervical sampling in a population of asymptomatic women. Women with abnormal cytology are more likely to have pre-invasive or invasive lesions and are referred for further testing, colposcopy. Colposcopy identifies suspicious areas and guides the best site for biopsy. In the situation of negative colposcopy and abnormal cytology, suspicion for high-grade lesion (HSIL). It recommends further investigation of the endocervical canal before the possible excisional procedure and obtaining an additional canal sample by brushing or curettage. However, to date, there is no consensus and studies lack consistent results on which is the best method for further investigation of the endocervix. Objectives: To compare the performance of additional strategies in the investigation and detection of precursor or invasive lesions in the endocervical canal in women with abnormal cytology (ASC H+) and with initial colposcopy without suspicious images.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 15, 2021
Enrollment StartSep 29, 2021
Primary CompletionSep 29, 2022
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 4.6 years ago

Interventions

Endocervical liquid-base cytologyother

Endocervical sample collected by brushing and preserved in a liquid-base.

Endocervical cell blockother

Endocervical sample collected by endocervical brush and preserved in a buffered formalin base for obtaining a "cell block" and evaluated as histology.

Endocervical curettageother

Endocervical sample obtained by curettage, preserved in buffered formalin, and evaluated as histology.