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.
- Keywords
- Cervical Cancer, Colposcopy, Conservative Management, High-Grade Cervical Dysplasia, Methylation,
- 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
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 São 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 São Paulo, Brazil.
- Keywords
- HPV, Pap smear, colposcopy, female inmates, prison,
- MeSH
- Adult MeSH
- Uterine Cervical Dysplasia * diagnosis MeSH
- Colposcopy * MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Uterine Cervical Neoplasms * diagnosis pathology MeSH
- Papanicolaou Test * MeSH
- Cross-Sectional Studies MeSH
- Retrospective Studies MeSH
- Vaginal Smears * MeSH
- Prisoners * MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Female MeSH
- Publication type
- Journal Article 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.
- Keywords
- Cancer, Cervix, Colposcopy, European guideline, Screening,
- 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
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.
- Keywords
- Cervical intraepithelial neoplasia, HPV, Non-surgical treatment, Silicon dioxide, Sodium selenite, p16/Ki-67 dual staining,
- 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
- Names of Substances
- Ki-67 Antigen MeSH
- Antioxidants MeSH
- Cyclin-Dependent Kinase Inhibitor p16 MeSH
- Citric Acid MeSH
- Biomarkers, Tumor MeSH
- Silicon Dioxide MeSH
- Sodium Selenite MeSH
- Vaginal Creams, Foams, and Jellies * MeSH
OBJECTIVE: Description of a case of extrapulmonary genital tuberculosis of the uterine cervix in a postmenopausal patient. CASE REPORT: A 66-year-old patient with a history of metrorrhagia, an ulcerated process in the area of the uterine cervix and vagina, with infiltration of parametria, serosanguinolent discharge and progressive cachectization was admitted to the oncogynecological center of the Hospital of České Budějovice, a.s. As part of the dia-gnostics, physical examination, colposcopy, targeted bio-psy, polymerase chain reaction (PCR) and microbio-logical examination, oncogynecological ultrasound and CT examination were performed. Clinically, the lesion acted as an advanced tumor. However, no malignant cells were detected in the bio-psy and the histopathological finding corresponded to a granulomatous inflammatory condition with giant cell histiocytic elements. Bacterial DNA of Mycobacterium tuberculosis complex was detected by PCR testing. The patient underwent controlled antituberculosis treatment with regular gynecological examinations. CONCLUSION: Tuberculosis of the uterine cervix occurs rarely. Its clinical manifestation may mimic the tumor process. Dia-gnosis is based on the identification of the causative agent and treatment consists of long-term controlled administration of antituberculotics, and in rare cases, combination with surgical treatment.
- Keywords
- Mycobacterium tuberculosis complex, extrapulmonar tuberculosis, genital tuberculosis, uterine cervix,
- MeSH
- Cervix Uteri MeSH
- Colposcopy MeSH
- Humans MeSH
- Postmenopause * MeSH
- Aged MeSH
- Pregnancy MeSH
- Tuberculosis * MeSH
- Vagina MeSH
- Check Tag
- Humans MeSH
- Aged MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
Human papillomavirus (HPV) has been directly related to acuminate warts and cervical cancer, the second most common neoplasia among women. Given the lack of treatment against the virus itself, many medications have been utilised, mainly aiming in modifying the host's immunological response. We present the case of a 54 years old postmenopausal patient with a history of vaginal cuff wart and HPV persistence that we managed in our clinic for 6 months with a mix of curcumin, aloe vera, amla and other natural ingredients. As the patient was found to be intolerant to imiquimod (one of the most common conservative methods of treatment) we attempted the use of curcumin, which was applied to the area of the wart three times per week for 6 months. Both clinical and colposcopical improvement was noted in regular clinic visits with regression of the lesion. The outcome of this case encourages our view that curcumin should be considered as a significant treatment modality against HPV infection and acuminate warts.
- Keywords
- CM-β glucans, Docosanol, HPV, Indian Grapefruit (AMLA), SiloffGyn, aloe vera, curcumin, lactic acid, vaginal cuff wart,
- MeSH
- Adjuvants, Immunologic adverse effects MeSH
- beta-Glucans therapeutic use MeSH
- Squamous Intraepithelial Lesions of the Cervix drug therapy pathology MeSH
- Drug Combinations MeSH
- Phytotherapy MeSH
- Imiquimod adverse effects MeSH
- Papillomavirus Infections drug therapy pathology MeSH
- Colposcopy MeSH
- Condylomata Acuminata drug therapy pathology MeSH
- Curcumin therapeutic use MeSH
- Lactic Acid therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Fatty Alcohols therapeutic use MeSH
- Papanicolaou Test MeSH
- Phyllanthus emblica MeSH
- Antineoplastic Agents therapeutic use MeSH
- Plant Preparations therapeutic use MeSH
- Vaginal Creams, Foams, and Jellies MeSH
- Vaginal Diseases drug therapy pathology MeSH
- Vaginal Smears MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
- Names of Substances
- Adjuvants, Immunologic MeSH
- beta-Glucans MeSH
- docosanol MeSH Browser
- Drug Combinations MeSH
- Imiquimod MeSH
- Curcumin MeSH
- Lactic Acid MeSH
- Fatty Alcohols MeSH
- Antineoplastic Agents MeSH
- Plant Preparations MeSH
- Vaginal Creams, Foams, and Jellies MeSH
OBJECTIVES: The aim of the EXPL-HPV-002 study is to evaluate the integration of 14 high-risk HPV as a biomarker of the severity and the progression of cervical lesions. Such a „triage biomarker“ would help to reduce the number of unnecessary colposcopies, to avoid over-treatment of lesions that spontaneously regress and to better target the lesions requiring treatment. DESIGN: EXPL-HPV-002 is a prospective, open-label, single arm, GCP study conducted at 2 clinical sites in the Czech Republic. SETTINGS: Investigations centers: Private Gynecology Center, Brno; Gynecological and Obstetrical Clinic, Brno; Genotyping central lab: NRL for Papillomaviruses and polyomaviruses, IHBT, Prague; Histology Central reading: Aeskulab Pathology, Prague; Molecular combing HPV test: Genomic Vision, Bagneux. METHODS: From June 2016 to May 2018, 688 patients aged 25-65, referred to colposcopy after an abnormal Pap-smear, were enrolled in the study. Among them 60% were found HPV high-risk. The study is divided in two phases: 1. a cross-sectional phase using data collected at first visit (colposcopy images ± histology, pap-smear for HPV genotyping and molecular combing) to study the association between HPV integration status versus colposcopy and histology grades; 2. a longitudinal phase using data collected in follow-up visits: cytology at 6, 18 and 30 months and colposcopy ± histology at 12, 24 and 36 months. A pap-smear collected at 12, 24 and 36 months allows to perform genotyping and molecular combing. HPV integration status is analyzed in comparison with the evolution of lesions, viral clearance and HPV genotype. HPV genotyping and molecular combing were performed on pap-smear samples in central laboratories. Histology data were reviewed by central reading. RESULTS: The transversal phase of the study is achieved and shows that the HPV integration into the human DNA, monitored by molecular combing, can significantly differentiate normal subjects from women with cervical lesions or cancer. CONCLUSION: HPV integration into the host genome, monitored by Genomic Visions technology, is a reliable diagnostic biomarker that will greatly help clinicians to improve their medical decision tree.
- Keywords
- Genomic Morse Code, HPV diagnostic, biomarker, cervical cancer, molecular combing, viral integration,
- MeSH
- Early Detection of Cancer methods MeSH
- DNA Probes, HPV MeSH
- DNA, Viral analysis MeSH
- Adult MeSH
- Papillomavirus Infections diagnosis virology MeSH
- Colposcopy * MeSH
- Middle Aged MeSH
- Humans MeSH
- Uterine Cervical Neoplasms diagnosis prevention & control virology MeSH
- Papillomaviridae genetics MeSH
- Prospective Studies MeSH
- Cross-Sectional Studies MeSH
- Aged MeSH
- Pregnancy MeSH
- Vaginal Smears * MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Czech Republic MeSH
- Names of Substances
- DNA Probes, HPV MeSH
- DNA, Viral MeSH
OBJECTIVE: To determine the risk of prolapse recurrence in patients after vaginal hysterectomy with colporrhaphy. DESIGN: Retrospective clinical study. SETTING: Department of Obstetrics and Gynaecology, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague. METHODS: The trial involved 220 women who underwent vaginal hysterectomy with anterior and posterior kolporrhaphy at our department for uterine prolapse at least grade 2. It was the first vaginal surgery in all of the patients. Subjective feeling of pressure in the vagina and/or palpable mass in the vagina or in front of the vaginal entrance and/or objective finding decline of the vaginal walls or fundus at lest the second degree or repeated surgery for prolapse were considered as a prolapse recurrence. RESULTS: The mean age at the time of vaginal hysterectomy was 66.7 years (range 37-88). Only 11 patients were premenopausal (5%), the others were postmenopausal, a mean time of posmenopause was 16.9 years. The average parity rate of the study group was 2.1. The average duration of the surgery was 68 minutes. Postoperative urinary retention was observed in one patient (0.45%). 156 women were enrolled in the study. The average length of follow-up was 47 months (minimum 24 months). Recurrence of prolapse based on subjective assessment occured in 24 patients (15.4 %) with pressure and resistance in the vaginal introitus. According to objective criteria, the recurrence of prolapse was diagnosed in 33 (21.2%) patients, of which 16 had prolapse of the anterior vaginal wall, three of the posterior vaginal wall (two rectocoele, one rectoenterocoele), eight combination prolapse of anterior and posterior vaginal wall and vaginal vault prolapse was diagnosed in six women. Eight patients (5. 1%) underwent surgery because of prolapse recurrence. The mean interval from primary surgery to the time of reoperation was 24.4 months (range 6-62). CONCLUSION: Patients have to be preoperatively informed about the risk of the prolapse recurrence with the recommendation of appropriate preventive arrangements.
- Keywords
- colporrhaphy, pelvic organ prolapse POP., recurrence, vaginal hysterectomy, vaginal vault prolapse,
- MeSH
- Adult MeSH
- Hysterectomy, Vaginal * MeSH
- Colposcopy * MeSH
- Middle Aged MeSH
- Humans MeSH
- Uterine Prolapse surgery MeSH
- Pelvic Organ Prolapse surgery MeSH
- Recurrence MeSH
- Retrospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Vagina surgery MeSH
- Treatment Outcome MeSH
- Plastic Surgery Procedures methods MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
Cervical precancerous lesions represented by cervical intraepithelial neoplasia (CIN) and cervical glandular intraepithelial neoplasia may progress to invasive cancer. The principle treatment of CIN is eradication of the transformation zone. However, all eradication methods are associated with some adverse events, particularly with perinatal consequences. It is therefore necessary to identify which women have CIN that has a low risk of transformation into invasive cancer. The presence of modifying factors can help to stratify CIN lesions according to their malignant potential. The evaluation of HPV genotype in particular holds great promise for defining patients at greater risk. Tailoring treatment to the individual patient is going to become a major consideration in the management of cervical precancerous lesions.
- MeSH
- Uterine Cervical Dysplasia pathology surgery virology MeSH
- Genotype MeSH
- Colposcopy MeSH
- Humans MeSH
- Cell Transformation, Neoplastic MeSH
- Biomarkers, Tumor analysis MeSH
- Uterine Cervical Neoplasms pathology surgery virology MeSH
- Retreatment MeSH
- Papillomaviridae genetics MeSH
- Precancerous Conditions pathology surgery virology MeSH
- Reproductive History MeSH
- Decision Making MeSH
- Age Factors MeSH
- Patient Selection * MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
- Names of Substances
- Biomarkers, Tumor MeSH
OBJECTIVE: This study aimed to assess the diagnostic value of the colposcopic feature of umbilication for detecting high-grade cervical intraepithelial neoplasia (CIN 2/3). MATERIALS AND METHODS: Study included 430 randomly selected women who underwent conization for CIN 2 or CIN 3. The control group consisted of 102 patients with biopsy-confirmed CIN 1. Colpophotographs and reports from colposcopy examinations from all patients were retrospectively analyzed by 2 independent colposcopy experts with the aim to assess the presence of umbilication. The occurrence of more than 2 mosaic "tiles" with central punctation was considered to be a positive finding regardless of whether the mosaic pattern was coarse or fine. The prevalence of umbilication in CIN 1 and CIN 2/3 respectively was compared. The diagnostic value of umbilication alone and combination of umbilication and/or ridge sign was assessed. RESULTS: Umbilication was detected in 10% and ridge sign in 10.2% of patients with CIN 2/3. Simultaneous presence of umbilication and ridge sign was rare (1.1%). The umbilication solely reached 12% sensitivity, 100% specificity, and 100% positive predictive value for the detection of underlying CIN 2/3. CONCLUSIONS: Umbilication is an age-independent colposcopic feature with very high specificity for predicting CIN 2/3.
- MeSH
- Cervix Uteri pathology MeSH
- Adult MeSH
- Uterine Cervical Dysplasia diagnosis pathology MeSH
- Cohort Studies MeSH
- Colposcopy methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Severity of Illness Index * MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Female MeSH
- Publication type
- Journal Article MeSH