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

NCT05231993 | Enrolling By Invitation

• 1 other identifier: AGC
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cervical cancer, atypical glandular cells

Outcome Measures

Primary Outcomes (1)

• CIN3+

  Proportion of women with histologically verified HSIL+ (CIN3+) including AIS+ after AGC found in screening

  2-3 years

Secondary Outcomes (1)

• CIN2+

  2-3 years

Study Arms (2)

Active comparator

ACTIVE COMPARATOR

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

Placebo comparator

PLACEBO COMPARATOR

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

Interventions

Conization PROCEDURE

A cone biopsy to remove abnormal tissue.

Also known as: Excision

Active comparator

Colposcopy PROCEDURE

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

Placebo comparator

Eligibility Criteria

• Age: 23 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• give informed consent
• Women diagnosed with AGC (atypical glandular cells, M69720) and HPV 16/18 positive, detected in cervical screening.

You may not qualify if:

• Do not give informed consent
• HPV negative or none-HPV16/18 positive

Sponsors & Collaborators

• Karolinska Institutet: lead
• Regional Cancer Centre Stockholm Gotland: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

• 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.

  PMID: 29247086 RESULT

• 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: 10.1136/bmj.i276.

  PMID: 26869597 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Conization; Colposcopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Minimally Invasive Surgical Procedures; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Kristina Elfgren, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 9, 2022
• Study Start: January 27, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)