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Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy

NCT05120167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Endocervical liquid-base cytology

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

DIAGNOSTIC_TEST

Endocervical cell block

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

DIAGNOSTIC_TEST

Endocervical curettage

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

Sponsors & Collaborators

  • Cirbia Silva Campos Teixeira

    lead OTHER

Principal Investigators

  • Cirbia SC Teixeira, MD · Hospital de Cancer de Barretos

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2022-09-29
Completion
2022-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120167 on ClinicalTrials.gov