Improving Diagnostic in Cervical Dysplasia: A Randomized Study With Local Estrogen Prior to Colposcopy

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Gynecology and Obstetrics
RECRUITING
Randers
Contact Information
Primary
Vibe M Bertelsen, MD, PhD student
vibebert@rm.dk
+4578421069
Backup
Isil Pinar Bor, Ass. professor
isipinbo@rm.dk
+4578421069
Time Frame
Start Date: 2023-08-23
Estimated Completion Date: 2025-07-16
Participants
Target number of participants: 150
Treatments
Active_comparator: Active estrogen
Will receive pretreatment with vaginal application of estrogen 30 microgram (three tablets) once a day for 14 days.
Placebo_comparator: Placebo
Will receive pretreatment with vaginal application with no estrogen (three tablets) once a day for 14 days.
Sponsors
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov