Clinical Triage and Treatment of Atypical Glandular Cells (AGC) Detected in Screening
Launched by KAROLINSKA INSTITUTET · Jan 29, 2022
Trial Information
Current as of November 09, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This trial is testing the best way to manage atypical glandular cells (AGC) found in cervical screening when HPV 16 or 18 is present. Participants are randomly assigned to one of two approaches: (1) immediate cone biopsy to remove tissue (conization) plus follow-up per guidelines, or (2) standard care with colposcopy and biopsy within 3 months, plus follow-up visits at about 12 and 24 months if needed. The goal is to see which method more effectively prevents high-grade cervical changes that could lead to cancer (CIN3+ or AIS) over the next 2–3 years.
The study is for adult women aged 23–64 who have AGC detected in screening and test positive for HPV 16 or 18, and who can give informed consent. It is being conducted in Stockholm, Sweden at Karolinska University Hospital, with about 280 participants planned. If you join, you’ll be randomly assigned to either the early tissue-removal approach or the standard colposcopy approach, and you’ll be followed for several years to determine which method better lowers the risk of serious cervical changes. Results are not yet available, and the trial is expected to finish its primary follow-up around 2025–2029.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • give informed consent
- • Women diagnosed with AGC (atypical glandular cells, M69720) and HPV 16/18 positive, detected in cervical screening.
- Exclusion Criteria:
- • Do not give informed consent
- • HPV negative or none-HPV16/18 positive
About Karolinska Institutet
Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, Sweden
Stockholm, Other, Sweden
Patients applied
Trial Officials
Kristina Elfgren, MD, PhD
Principal Investigator
Karolinska University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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