Status:
NOT_YET_RECRUITING
Large Loop Excision of the Transformation Zone During Follicular Vs. Luteal Phase of the Menstrual Cycle (LLETZ-MC)
Lead Sponsor:
Ruhr University of Bochum
Conditions:
Cervical Dysplasia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Cervical cancer is one of the most common cancers in women and one of the leading causes of death in women worldwide. Pre-cancerous lesions (dysplasias) are detected by the preventive smear test at th...
Detailed Description
HPV and dysplasia of the uterine cervix Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide. The prevalence in both male and female populations is high. Epidemio...
Eligibility Criteria
Inclusion
- Written consent
- Regular menstrual cycle, defined as an interval between 21 and 35 days and a bleeding duration between 3 and 10 days during the last 3 months
- Colposcopy performed preoperatively
- Histologically (by previously performed colposcopy) confirmed dysplasia (CIN 1, CIN 2 or CIN 3)
- Suspicion of low-grade or high-grade squamous intraepithelial lesion based on Papanicolaou smear with inconclusive colposcopy and need for surgical workup to exclude lesions
- Age \>18 years
Exclusion
- Pregnant patients
- Patients with insufficient knowledge of the German language
- Pre-existing oncological diseases
- Blood coagulation disorders
- Taking blood thinning substances
- Use of a hormonal intrauterine device (e.g. Mirena);
- Use of a progesterone pill or progesterone injectate;
- Use of long cycle contraceptive (no monthly bleeding).
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05391243
Start Date
March 1 2025
End Date
December 1 2026
Last Update
January 31 2025
Active Locations (1)
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1
Marien Hospital Herne
Herne, North Rhine-Westphalia, Germany, 44625