Improving Diagnostic in Cervical Dysplasia: A Randomized Study With Local Estrogen Prior to Colposcopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Scoring of the visibility of the Squamous columnar junction (SCJ)
Study Overview
Brief 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.
Detailed Description
Cervical cancer is the fourth most common cancer in women worldwide, and comprises approximately 7% of all new cancers in women. To reduce the disease burden, accurate and timely diagnosis of cervical precancerous lesions are crucial.
Aim:
The aim of this study is to evaluate whether optimizing present procedures can improve diagnosis of precancerous cervical lesions.
The study aims to:
1. Initiate a double blind study to investigate, if the diagnosis of cervical precancerous lesions can be improved among elderly women aged ≥ 50 years, by providing pretreatment with vaginal estrogen prior to the colposcopic examination.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Care Provider)
Masking Description
A randomization code will be made and given to the hospital pharmacy who will be packing and blind the tablets for the study. The study medicine will be sent to the women with the same/equal etiquette. At the gynecological examination, the colposcopist will not know which study arm the woman is in.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Placebo
Will receive pretreatment with vaginal application with no estrogen (three tablets) once a day for 14 days.
Intervention: Placebo (Diagnostic Test)
Active estrogen
Will receive pretreatment with vaginal application of estrogen 30 microgram (three tablets) once a day for 14 days.
Intervention: Estrogen (Diagnostic Test)
Outcomes
Primary Outcomes
Scoring of the visibility of the Squamous columnar junction (SCJ)
Time Frame: through study completion, an average of 1 year
Scoring of the visibility of the SCJ by the colposcopist as visible (TZ1), partly visible (TZ2) or not visible (TZ3) during colposcopic examination.
Number of patients with representation of the transformation zone in the cervical biopsies.
Time Frame: through study completion, an average of 1 year
Representation of the transformation zone in the cervical biopsies from all patients, evaluating from the pathology registration. When the transformation zone is present, the biopsies have been taken in the correct location of the cervix.
Secondary Outcomes
- Vaginal microbiome(through study completion, an average of 1 year)
- The patients' report on possible side effects during pretreatment through questionnaire(through study completion, an average of 1 year)
- Evaluate the proportion of CIN2+ found in biopsies.(1 month after the biopsy was collected at colposcopy)
- diagnostic conus.(1 month after the biopsy was collected)
- Evaluation of biopsies(1 month after the biopsy was collected at colposcopy)