Improving Diagnostics in Cervical Dysplasia

Cervical cancer is the fourth most common cancer in women worldwide. It is caused by an infection with human papillomavirus (HPV). A persistent infection with HPV is associated with increased risk of precancerous lesions, which may further develop into cervical cancer. To reduce the disease burden, accurate and timely diagnosis of cervical precancerous lesions are crucial. To identify cervical precancerous lesions, women are referred to colposcopy, which is the most important diagnostic tools to detect cervical precancerous lesions. It allows close visualization of the cervix in order to collect biopsies in the area called transformation zone (TZ), which is where precancerous lesions develop. It is essential for the physician to identify the TZ during colposcopy in order to obtain correct diagnosis. For women aged ≥50 this is often a challenge as TZ naturally with age, will retract further into the cervical canal, making the area for sampling invisible, and thereby the colposcopy inadequate. Consequently, this increases the risk of developing cancer due to diagnostic delay, and the risk of several colposcopy examinations or overtreatment (cone biopsy), before a final diagnosis is achieved. Few studies suggest that pretreatment with local vaginal estrogen prior to colposcopy may improve visualization of the TZ. Thereby, obtaining more accurate biopsies from the cervix, and thus making a more accurate and timely diagnosis in the first outpatient visit. The primary purpose of this study is to evaluate pre-diagnostic treatment with estrogen to improve the diagnosis of women with cervical precancerous lesions, in order to prevent cervical cancer. The study ia s randomized controlled double-blind multicenter study. The investigators will use information from Danish National Patient registry, and data from the Danish Pathology Data Bank. Enrollment will take place at the Departments of Gynecology in Denmark. Eligible women aged ≥ 50 years will be randomized 1:1 to receive local vaginal estrogen or placebo prior to the colposcopic examination. The investigators believe the results will provide the prerequisite for obtaining correct diagnosis, and thereby provide basis for choosing the right individualized examination- and treatment plan. The results will also contribute with important knowledge, that may help reduce the incidence and mortality rate of cervical cancer.

Sex

Female

Minimum age

50 Years

Inclusion Criteria:

* Postmenopausal (defined as no bleeding ≥1 year) women referred for colposcopy aged ≥ 50 years.
* Women referred for colposcopy due to a positive HPV test and/or an abnormal cervical cytology.
* Women referred for colposcopy due to previous abnormal cervical histology with minimum 6. months since last colposcopy with biopsies.

Exclusion Criteria:

* Use of estrogen within the last 3 months regardless of administration form.
* previous cervical radiotherapy, cervical amputation and/or cone biopsy
* pregnancy

• DERIVEDBertelsen VM, Tranberg M, Petersen LK, Booth B, Bor P. Improving diagnostic of cervical dysplasia among postmenopausal women aged >/=50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study). BMJ Open. 2024 Jun 23;14(6):e082833. doi: 10.1136/bmjopen-2023-082833. PMID 38910002