BACKGROUND: Avoiding conization may reduce the risk of pre-term labor in future pregnancies, making conservative treatment of high-grade cervical dysplasia an increasingly discussed approach, especially for younger patients. However, data on the integration of individual predictive factors into routine clinical practice remain limited. PRIMARY OBJECTIVE: The primary objective of the Regression of High-Grade Squamous Intraepithelial Cervical Lesions and Associated Risk Factors (RECER) study is to assess the rate of spontaneous regression in high-grade cervical squamous dysplasia (cervical intraepithelial neoplasia [CIN] 2 and 3) and identify associated predictive factors within clinical practice, without necessitating conization. STUDY HYPOTHESIS: We hypothesize that the characterization of cervical lesions, including colposcopic findings and patient-specific factors, along with a sufficient rate of spontaneous regression, will aid in identifying a subgroup of patients who may derive the greatest benefit from conservative management of high-grade cervical lesions. TRIAL DESIGN: The RECER trial is a multi-center prospective cohort study. Patients with histologically confirmed high-grade squamous intraepithelial lesions (CIN 2 or 3) undergo colposcopic assessments every 4 months. Colposcopic images are compared to evaluate lesion dynamics. In case of progression, conization is indicated, whereas in case of regression, documentation of a biopsy with low-grade dysplasia (CIN 1) or no dysplasia is required. Patients with stable disease are further followed up. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients aged 18 to 40 years with bioptically confirmed high-grade lesion (CIN 2 or 3), a fully visible squamo-columnar junction, and a willingness to undergo conservative management can be included. Excluded are patients with unsatisfactory colposcopy, pregnancy, glandular lesions, invasive disease, or a history of treatment for severe cervical dysplasia. PRIMARY ENDPOINT: The primary end point is the regression rate of high-grade cervical dysplasia. SAMPLE SIZE: 300 patients ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: As of October 2024, a total of 127 patients have been recruited from 4 participating sites across 3 countries. Estimated date of last patient enrollment: September 2026; estimated date for results presentation: January 2028. TRIAL REGISTRATION: Clinicaltrials.gov: NCT06147388.
- MeSH
- Squamous Intraepithelial Lesions of the Cervix * diagnosis pathology MeSH
- Adult MeSH
- Uterine Cervical Dysplasia * diagnosis pathology MeSH
- Colposcopy MeSH
- Conization adverse effects MeSH
- Humans MeSH
- Young Adult MeSH
- Multicenter Studies as Topic MeSH
- Uterine Cervical Neoplasms * diagnosis pathology prevention & control MeSH
- Observational Studies as Topic MeSH
- Prospective Studies MeSH
- Risk Factors MeSH
- Remission, Spontaneous * MeSH
- Neoplasm Grading MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Young Adult MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
Cíl: Cílem této studie bylo vyhodnotit nálezy v Pap stěru a kolposkopii u vězeňkyň ve vězeňské jednotce ve státě S?o Paulo, Brazílie. Metody: Retrospektivní průřezová studie byla provedena analýzou Pap stěru a kolposkopického vyšetření vězeňkyň ve vězeňské jednotce. Byly hodnoceny následující sociodemografické údaje: věk, národnost, úroveň vzdělání, rodinný stav, výška, hmotnost, etnický původ, povolání, náboženství, sexuální orientace a přítomnost tetování. Výsledky: Vzorek tvořilo 894 žen, které měly Pap stěr, z nichž většina byly Brazilky (93,6 %), 41,1 % mělo neúplné základní vzdělání, 58,5 % bylo svobodných, 50,1 % byly bělošky, 60,7 % mělo tetování a převládajícím náboženstvím bylo katolické 42,8 %. Pokud jde o sexuální orientaci, označilo se 124 žen (13,9 %) za bisexuální, 640 (71,6 %) za heterosexuální a 127 (14,2 %) za homosexuální. Většina Pap stěrů vykazovala benigní nálezy (86,5 %). Z vězeňkyň, které měly Pap stěr, bylo 121 (13,5 %) odesláno na kolposkopii. Změněný nález kolposkopie se vyskytl u 95 žen (10,6 %), přičemž nejčastější byl nález high-grade skvamózní intraepiteliální léze vysokého stupně u 36 žen (4,0 %) a low-grade skvamózní intraepiteliální léze nízkého stupně u 27 žen (3,0 %). Většina žen (96,0 %) neměla žádné klinické známky lidského papilomaviru – HPV (anogenitální verukózní léze) a pouze 36 (4,0 %) mělo na Pap stěrech léze připomínající HPV. Více případů HIV bylo ve skupině s HPV verukózními lézemi (p = 0,013). Závěr: Pozorovali jsme 13,5 %, resp. 78,5 % abnormálních nálezů v Pap stěru a kolposkopii u vězeňkyň ve vězeňské jednotce ve státě S?o Paulo v Brazílii.
Objective: The objective of this study was to evaluate the Pap smear and colposcopy findings in female inmates in a prison unit in the state of S?o Paulo, Brazil. Methods: A retrospective cross-sectional study was carried out by analyzing the Pap smear and colposcopy examinations of female inmates in a prison unit. The following socio-demographic data were assessed: age, nationality, level of education, marital status, height, weight, ethnicity, occupation, religion, sexual orientation, and presence of tattoos. Results: The sample consisted of 894 women who had a Pap smear, the majority of whom were Brazilian (93.6%), 41.1% had an incomplete primary education, 58.5% were single, 50.1% were white, 60.7% had tattoos, and the predominant religion was Catholicism at 42.8%. Regarding sexual orientation, 124 (13.9%) women identified as bisexual, 640 (71.6%) as heterosexual, and 127 (14.2%) as homosexual. Most Pap smears showed benign findings (86.5%). Of the female inmates who had a Pap smear, 121 (13.5%) were referred for colposcopy. Altered colposcopy findings occurred in 95 (10.6%), with the most common findings being high-grade squamous intraepithelial lesions 36 (4.0%) and low-grade squamous intraepithelial lesions 27 (3.0%). The majority of women (96.0%) had no clinical signs of human papillomavirus – HPV (anogenital verrucous lesions) and only 36 (4.0%) had lesions suggestive of HPV on Pap smears. There were more HIV cases in the group with HPV verrucous lesions (P = 0.013). Conclusion: We observed 13.5% and 78.5% of abnormal findings in Pap smears and colposcopy, resp.), in female inmates in a prison unit in the state of S?o Paulo, Brazil.
- MeSH
- Papillomavirus Infections diagnosis complications MeSH
- Colposcopy * methods MeSH
- Humans MeSH
- Uterine Cervical Neoplasms diagnosis prevention & control MeSH
- Papanicolaou Test * methods MeSH
- Retrospective Studies MeSH
- Prisoners * statistics & numerical data MeSH
- Check Tag
- Humans MeSH
- Geographicals
- Brazil MeSH
BACKGROUND: Following the publication of the European consensus statement on standards for essential colposcopy in 2020, the need for standards relating to more complex and challenging colposcopy practice was recognised. These standards relate to colposcopy undertaken in patients identified through cervical screening and tertiary referrals from colposcopists who undertake standard colposcopy only. This set of recommendations provides a review of the current literature and agreement on care for recognised complex cases. With good uptake of human papillomavirus (HPV) immunisation, we anticipate a marked reduction in cervical disease over the next decade. Still, the expert colposcopist will continue to be vital in managing complex cases, including previous cervical intraepithelial neoplasia (CIN)/complex screening histories and multi-zonal disease. AIMS: To provide expert guidance on complex colposcopy cases through published evidence and expert consensus. MATERIAL & METHODS: Members of the EFC and ESGO formed a working group to identify topics considered to be the remit of the expert rather than the standard colposcopy service. These were presented at the EFC satellite meeting, Helsinki 2021, for broader discussion and finalisation of the topics. RESULTS & DISCUSSION: The agreed standards included colposcopy in pregnancy and post-menopause, investigation and management of glandular abnormalities, persistent high-risk HPV+ with normal/low-grade cytology, colposcopy management of type 3 transformation zones (TZ), high-grade cytology and normal colposcopy, colposcopy adjuncts, follow-up after treatment with CIN next to TZ margins and follow-up after treatment with CIN with persistent HPV+, and more. These standards are under review to create a final paper of consensus standards for dissemination to all EFC and ESGO members.
- MeSH
- Early Detection of Cancer MeSH
- Uterine Cervical Dysplasia * diagnosis MeSH
- Papillomavirus Infections * diagnosis MeSH
- Colposcopy MeSH
- Humans MeSH
- Uterine Cervical Neoplasms * MeSH
- Papillomaviridae MeSH
- Pregnancy MeSH
- Check Tag
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- MeSH
- Medical History Taking MeSH
- Diagnostic Techniques, Obstetrical and Gynecological MeSH
- Gynecological Examination * methods MeSH
- Clinical Laboratory Techniques methods MeSH
- Colposcopy methods MeSH
- Humans MeSH
- Genitalia, Female diagnostic imaging MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Review MeSH
PURPOSE: The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated. METHODS: 216 women aged 25-60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed. RESULTS: Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present. CONCLUSION: SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer. TRIAL REGISTRATION NUMBER: ISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040 ; retrospectively registered.
- MeSH
- Ki-67 Antigen drug effects MeSH
- Antioxidants administration & dosage MeSH
- Administration, Intravaginal MeSH
- Cytodiagnosis MeSH
- Adult MeSH
- Uterine Cervical Dysplasia pathology therapy MeSH
- Genes, p16 MeSH
- Papillomavirus Infections therapy virology MeSH
- Cyclin-Dependent Kinase Inhibitor p16 drug effects MeSH
- Colposcopy MeSH
- Citric Acid administration & dosage MeSH
- Middle Aged MeSH
- Humans MeSH
- Biomarkers, Tumor analysis MeSH
- Uterine Cervical Neoplasms prevention & control MeSH
- Silicon Dioxide administration & dosage MeSH
- Sodium Selenite administration & dosage MeSH
- Pregnancy MeSH
- Vaginal Creams, Foams, and Jellies * MeSH
- Vaginal Smears MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
