An interventional study of Conization and Colposcopy in Uterine Cervical Cancer, sponsored by Karolinska Institutet. Enrolling by invitation at 1 site in Sweden. Open to female participants aged 23 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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.
Evidence from a nationwide cohort study demonstrated that the risk of cervical cancer following a diagnosis of AGC detected in screening was elevated for 15 years, particularly the risk of adenocarcinoma. Furthermore, the study suggested that compared to high-grade squamous intraepithelial lesion (HSIL) management, the management of AGC has been suboptimal in Sweden (Wang et al., BMJ 2016). A study conducted in the greater metropolitan region of Stockholm showed that the PPV for high grade lesions was 60% for Human Papillomavirus (HPV) positive AGC detected in screening (Norman et al., BMJ Open, 2017).
The new guidelines for cervical cancer prevention were adopted in January of 2017 nationally and in December 2017 in county of Stockholm and outline a clinical management strategy for AGC. The recommendation is that AGC detected in screening, regardless of HPV status, should be referred to a gynecologist for colposcopy with biopsy within 3 months of the index test. For women over the age of 40, an ultrasound and endometrial biopsy is also recommended. Repeat tests should be done at one year and two years, if these are negative then the woman can return to routine screening.
The elevated risk for high grade lesions and cancer associated with AGC, coupled with the reality that cervical cancer incidence has increased in Sweden, begs a new evaluation of the optimal clinical management and treatment of AGC detected in screening. Women will be randomized to routine management according to the new guidelines or to an alternative management.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 280 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
1. All women ages \<41, women ages ≥41 with TZ1 and TZ2, and women ages ≥41 with a desire for further childbearing Clinical management and follow-up according to the national screening guidelines published in 2017 (same as for the comparator group, see below). 2. Women with TZ3 and women ages ≥41 with no desire for further childbearing a. Referral to (diagnostic) excision. The depth of the diagnostic excision will be clinically determined in the trial. It should be with the intent to treat but no so extensive that the risk for side effects increases. The excision should include a cervical abrasion and endometrial sampling.
Procedure: Conization
Clinical management and follow-up according to the national screening guidelines published in 2017: 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
Procedure: Colposcopy
A cone biopsy to remove abnormal tissue.
Also known as: Excision
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
CIN3+
Proportion of women with histologically verified HSIL+ (CIN3+) including AIS+ after AGC found in screening
Time frame: 2-3 years
CIN2+
Proportion of women with histologically verified HSIL+ (CIN2+) including AIS+ after AGC found in screening
Time frame: 2-3 years
Plan to share: Yes — To be determined.
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