scholarly journals Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial

2020 ◽  
Author(s):  
Attila Louis Major ◽  
Vladimír Dvořák ◽  
Jana Schwarzová ◽  
Aleš Skřivánek ◽  
Tomáš Malík ◽  
...  
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Intraepithelial Neoplasia ◽  
Cervical Lesions ◽  
Ki 67 ◽  
Vaginal Gel ◽  
Registration Number ◽  
High Risk Hpv ◽  
Non Destructive

Abstract 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.

scholarly journals An Adsorptive and Antioxidant Vaginal Gel Clears High-Risk HPV- and p16/Ki-67-Associated Abnormal Cytological Cervical Findings: A post-hoc Subgroup Analysis of a Prospective Randomized Controlled Trial on CIN2 and p16 Positive CIN1

2021 ◽  
Vol 8 ◽  
Author(s):  
Attila Louis Major ◽  
Ales Skřivánek ◽  
Etienne Marc Grandjean ◽  
Vladimír Dvořák ◽  
Tomáš Malík ◽  
...  
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Status Change ◽  
Clinical Trial Registration ◽  
Ki 67 ◽  
Vaginal Gel ◽  
Prospective Randomized Controlled Trial ◽  
Effective Option ◽  
High Risk Hpv ◽  
Post Hoc

Objective: To analyze the course of p16/Ki-67-positive abnormal cytological cervical findings and high risk (hr)-HPV- and p16/Ki-67-clearances in women treated with a vaginal gel.Methods: 172 women with a histological diagnosis of CIN2 or p16-positive CIN1 lesions were selected based on a positive cytological p16/Ki-67 test. For 3 months, 75 patients in the active arm (AA) daily administered 5 ml of a vaginal gel. Ninety seven patients in the control arm (CA) underwent no treatment (“watchful waiting”). Endpoints were cytological evolution, p16/Ki-67- and hr-HPV-clearances.Results: At 3 months, cytological regression was observed in 76% (57/75) of patients in the AA compared with 25% (24/97) in the CA. Progression occurred in 5% (4/75) of the AA compared with 15% (15/97) of the CA. The p16/Ki-67 status change was statistically significantly (p &lt; 0.001) in favor of the AA: 77% (58/75) became negative compared to 21% (20/97) in the CA. hr-HPV prevalence decreased significantly (p &lt; 0.001) in the AA from 87 to 44%, while increasing in the CA from 78 to 84%. Cytological regression and p16/Ki-67 changes persisted in the AA at 6 months.Conclusions: The vaginal gel significantly cleared hr-HPV and p16/Ki-67 and was associated with improved cytological findings, thereby potentially offering an effective option against oncogenic risk.Clinical Trial Registration: Identifier: [ISRCTN11009040].

Comparison of Human Papillomavirus Detection and Typing by Hybrid Capture 2, Linear Array, DNA Chip, and Cycle Sequencing in Cervical Swab Samples

2009 ◽  
Vol 19 (2) ◽  
pp. 266-272 ◽  
Author(s):  
Jae Kwan Lee ◽  
Mi Kyung Kim ◽  
Seung Hun Song ◽  
Jin Hwa Hong ◽  
Kyung Jin Min ◽  
...  
Keyword(s):  
High Risk ◽  
Linear Array ◽  
Intraepithelial Neoplasia ◽  
Dna Chip ◽  
Substantial Agreement ◽  
Cervical Lesions ◽  
Cycle Sequencing ◽  
Hpv Dna ◽  
Hpv Dna Tests ◽  
High Risk Hpv

Although the Hybrid Capture II (HC II) assay can detect 13 high-risk human papillomavirus (HPVs), it does not yield any genotype-specific information. We evaluated the performance of 4 HPV DNA tests, namely, HC II, Linear Array (LA), DNA chip, and cycle sequencing for their capacity to detect the presence of high-risk HPV DNA and HPV-associated cervical lesions. Seventy-six women who were referred to the colposcopy clinic for abnormal cytology were enrolled. The women were examined using liquid-based cytology, colposcopy-directed biopsy, and HPV DNA tests. After DNA extraction from a single sample, HPV DNA tests were performed by all 4 methods on the same specimen. The LA test has higher HPV-positive rates than HC II for cervical intraepithelial neoplasia I (83.3% vs 61.1%;P< 0.01) and for cervical intraepithelial neoplasia II and more severe lesions (100.0% vs 80.0%;P< 0.01). The concordance between the DNA chip and LA tests was 89.5%, confirming substantial agreement (κcoefficient = 0.73), and the concordance between HC II and the DNA chip was 80.3%, also showing substantial agreement (κcoefficient = 0.738). The concordance for 15 high-risk HPV genotypes between LA and sequencing was 82.5% with aκvalue of 0.536. Furthermore, the LA test was more sensitive in the detection of high-grade cervical lesions than HC II (100% vs 92.3%,P< 0.01). The LA test showed superior sensitivity in the detection of clinically relevant HPV infections and has proven to be an accurate tool for identifying individual HPV types, especially in cases of multiple HPV infections.

scholarly journals Associations between the expression of SCCA, MTA1, P16, Ki‑67 and the infection of high‑risk HPV in cervical lesions

2020 ◽  
Vol 20 (1) ◽  
pp. 884-892 ◽  
Author(s):  
Cuina Han ◽  
Fangfei Zhao ◽  
Chongyang Wan ◽  
Yanfang He ◽  
Yan Chen
Keyword(s):  
High Risk ◽  
Cervical Lesions ◽  
Ki 67 ◽  
High Risk Hpv

scholarly journals Multistate Markov Model to Predict the Prognosis of High-Risk Human Papillomavirus-Related Cervical Lesions

Cancers ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 270 ◽  
Author(s):  
Ayumi Taguchi ◽  
Konan Hara ◽  
Jun Tomio ◽  
Kei Kawana ◽  
Tomoki Tanaka ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Markov Model ◽  
Continuous Time ◽  
Retrospective Cohort ◽  
Intraepithelial Neoplasia ◽  
Cervical Lesions ◽  
History Of ◽  
The University ◽  
High Risk Hpv

Cervical intraepithelial neoplasia (CIN) has a natural history of bidirectional transition between different states. Therefore, conventional statistical models assuming a unidirectional disease progression may oversimplify CIN fate. We applied a continuous-time multistate Markov model to predict this CIN fate by addressing the probability of transitions between multiple states according to the genotypes of high-risk human papillomavirus (HPV). This retrospective cohort comprised 6022 observations in 737 patients (195 normal, 259 CIN1, and 283 CIN2 patients at the time of entry in the cohort). Patients were followed up or treated at the University of Tokyo Hospital between 2008 and 2015. Our model captured the prevalence trend satisfactory, particularly for up to two years. The estimated probabilities for 2-year transition to CIN3 or more were the highest in HPV 16-positive patients (13%, 30%, and 42% from normal, CIN1, and CIN2, respectively) compared with those in the other genotype-positive patients (3.1–9.6%, 7.6–16%, and 21–32% from normal, CIN1, and CIN2, respectively). Approximately 40% of HPV 52- or 58-related CINs remained at CIN1 and CIN2. The Markov model highlights the differences in transition and progression patterns between high-risk HPV-related CINs. HPV genotype-based management may be desirable for patients with cervical lesions.

Implementation of a Cervical Cancer Screening Strategy Using HPV Self-Sampling for Women Living in Rural Areas

2019 ◽  
Vol 64 (1-2) ◽  
pp. 7-15 ◽  
Author(s):  
Júlio Cesar Possati-Resende ◽  
Fabiana de Lima Vazquez ◽  
Naitielle de Paula Pantano ◽  
José Humberto Tavares Guerreiro Fregnani ◽  
Edmundo Carvalho Mauad ◽  
...  
Keyword(s):  
High Risk ◽  
Rural Communities ◽  
Rural Areas ◽  
Intraepithelial Neoplasia ◽  
Low Grade ◽  
Study Group ◽  
Cervical Lesions ◽  
Cancer Risks ◽  
Local Police ◽  
High Risk Hpv

Background: The implementation of population screening for cervical lesions in rural areas has been particularly challenging for a variety of reasons, including geographic isolation, limited access to medical care, lack of awareness of cancer risks, lower education levels, and embarrassment about having the clinical examination. Methods: This study was designed to evaluate the use of self-sampling for human papillomavirus (HPV) screening in the rural communities served by our hospital. To develop the study group, we trained a local police officer who was already interacting with the rural community to explain cancer risks and the ease of self-sampling to the women. Results: We identified a study group of 386 women, of whom 369 (95.6%) agreed to participate in the study. To test for high-risk HPV, we performed the Cobas PCR test, and of 340 valid samples, 45 (12.2%) were positive for at least 1 of the high-risk HPV subtypes. All positively tested women were referred for colposcopy and Papanicolaou testing. The follow-up biopsies showed that 40% had low-grade intraepithelial neoplasia (CIN1), 6.6% had high-grade intraepithelial neoplasia (CIN2/3), and 4.4% had squamous cell carcinoma. Conclusions: Self-collection for HPV testing by women living in isolated communities is highly efficient and has potential for cost-effective screening by taking advantage of existing support networks, such as the local police service.

The effectiveness of human papillomavirus load, reflected by cycle threshold values, for the triage of HPV-positive self-samples in cervical cancer screening

2020 ◽  
pp. 096914132094363
Author(s):  
Fangbin Song ◽  
Hui Du ◽  
Chun Wang ◽  
Xia Huang ◽  
Xinfeng Qu ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Intraepithelial Neoplasia ◽  
Threshold Value ◽  
Hpv Testing ◽  
Cervical Lesions ◽  
Squamous Cells ◽  
Cycle Threshold ◽  
Viral Loads ◽  
High Risk Hpv

Objective The performance of Cobas4800 cycle threshold value (Ct-value, reflecting viral load) combined with human papillomavirus (HPV) 16/18 genotyping was explored as a method of risk stratification to triage patients after primary HPV screening of self-collected samples. Methods The Chinese Multi-site Screening Trial database was reviewed, with focus on self-collected samples, using the results of Cobas4800 HPV assay. Quartiles of Ct-values of each genotype were used for grouping and developing screening algorithms. Diagnostic accuracy for paired comparisons between algorithms was obtained using McNemar’s test. Results A total of 10,498 women were included. The Ct-values of HPV16 and other high-risk HPV were inversely correlated with the severity of cervical lesions ( p < 0.001). Risks for cervical intraepithelial neoplasia (CIN2+/CIN3+) were significantly stratified by Ct-values from channels detecting HPV16 and other high-risk HPV types. “HPV with HPV16/18 and reflex Ct <33.7” (algorithm G) achieved a favorable sensitivity to “HPV with atypical squamous cells of undetermined significance or worse (≥ASCUS)” (81.9% vs. 70.1% for CIN2+, p < 0.001), a comparable sensitivity to “HPV with HPV16/18 reflex cytology ≥ASCUS” (81.9% vs. 81.3% for CIN2+, p > 0.05), and resulted in a slightly lower specificity than the latter two algorithms (92.6% vs. 97.4% and 95.4% respectively for CIN2+, p < 0.05). However, algorithm G achieved a comparable sensitivity to HPV testing alone for CIN3+, and reduced the colposcopy referral rate from 13.7% for HPV testing alone to 8.4%. Conclusions HPV viral loads reflected by Ct-values are associated with the severity of cervical lesions. Ct-values with an appropriate cut-off of 33.7, combined with HPV16/18 genotyping, represent a promising triage of HPV-positive women particularly for self-collected samples.

Sign in / Sign up

Export Citation Format

Share Document