Uterine Cervical Cancer Clinical Trial
Official title:
Clinical Triage and Treatment of Atypical Glandular Cells (AGC) Detected in Screening: Randomized Healthservices Trial
Verified date | April 2023 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 280 |
Est. completion date | December 2029 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 23 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Karolinska University Hospital, Regional Cancer Centre Stockholm Gotland |
Sweden,
Norman I, Hjerpe A, Dillner J. Risk of high-grade lesions after atypical glandular cells in cervical screening: a population-based cohort study. BMJ Open. 2017 Dec 14;7(12):e017070. doi: 10.1136/bmjopen-2017-017070. — View Citation
Wang J, Andrae B, Sundstrom K, Strom P, Ploner A, Elfstrom KM, Arnheim-Dahlstrom L, Dillner J, Sparen P. Risk of invasive cervical cancer after atypical glandular cells in cervical screening: nationwide cohort study. BMJ. 2016 Feb 11;352:i276. doi: 10.113 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CIN3+ | Proportion of women with histologically verified HSIL+ (CIN3+) including AIS+ after AGC found in screening | 2-3 years | |
Secondary | CIN2+ | Proportion of women with histologically verified HSIL+ (CIN2+) including AIS+ after AGC found in screening | 2-3 years |
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