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Clinical Triage and Treatment of Atypical Glandular Cells (AGC) Detected in Screening

NCT05231993 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-03-19

No results posted yet for this study

Summary

The risk of cervical cancer after diagnosis with atypical glandular cells (AGC) detected by screening is elevated for 15 years after discovery. The current recommendation is that when AGC is detected during screening, referel is made to a gynecologist for colposcopy with biopsy within 3 months after the index test. Repeated tests should be done after one year and after two years and if these are negative, the woman can return to routine screening.

Given the increased risk of cancer associated with AGC a new evaluation of the optimal follow-up and treatment of AGC, which is detected during screening, is carried out. In this randomized study, women with AGC will be randomized to routine treatment according to current guidelines or to conization. The aim of the study is to determine which of the two treatments is most effective.

Conditions

  • Uterine Cervical Cancer

Interventions

PROCEDURE

Conization

A cone biopsy to remove abnormal tissue.

PROCEDURE

Colposcopy

1. Colposcopy with biopsy within 3 months,endocervical sample, ultrasound and endometrial biopsy if the woman is ≥40 2. Colposcopy after 12 months if the first colposcopy and biopsies are normal 3. Cytology and HPV testing at 12 and 24 months if the second colposcopy is normal

Sponsors & Collaborators

  • Regional Cancer Centre Stockholm Gotland

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Kristina Elfgren, MD, PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2025-12-31
Completion
2029-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

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 NCT05231993 on ClinicalTrials.gov