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Background According to international guidelines, Human Papillomavirus (HPV) DNA tests represent a valid alternative to Pap Test for primary cervical cancer screening, provided that they guarantee balanced clinical sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or more (CIN2+) lesions. The study aimed to assess whether HPV Selfy (Ulisse BioMed – Trieste, Italy), a full-genotyping HPV DNA test that detects and differentiates 14 high-risk HPV (HR-HPV) types, meets the criteria for primary cervical cancer screening described in the international guidelines, on clinician-collected as well as on self-collected samples. Methods For each participant woman, consecutively referring to Azienda Sanitaria Universitaria Giuliano Isontina (Trieste, Italy) and CRO—National Cancer Institute (Aviano, Italy) for the cervical cancer screening program, the following samples were tested: (a) a clinician-collected cervical specimen, analyzed with the reference test (Hybrid Capture®2 test, HC2) and HPV Selfy; and (b) a self-collected vaginal sample, analyzed with HPV Selfy. Enrolled women were also asked to fulfill a questionnaire about self-sampling acceptability. As required by guidelines, a non-inferiority test was conducted to compare the clinical performance of the test under evaluation with its reference test. Results HPV Selfy clinical sensitivity and specificity resulted non-inferior to those of HC2. By analysis of a total of 889 cervical liquid-based cytology samples from a screening population, of which 98 were from women with CIN2+, HPV Selfy showed relative sensitivity and specificity for CIN2+ of 0.98 and 1.00 respectively (non-inferiority score test: P  = 0.01747 and P  = 0.00414, respectively); the test reached adequate intra- and inter-laboratory reproducibility. Moreover, we demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimen (0.92 relative sensitivity and 0.97 relative specificity). Finally, through HPV Selfy genotyping, we were able to describe HPV types prevalence in the study population. Conclusions HPV Selfy fulfills all the requirements of the international Meijer’s guidelines and has been clinically validated for primary cervical cancer screening purposes. Moreover, HPV Selfy has also been validated for self-sampling according to VALHUDES guidelines. Therefore, at date, HPV Selfy is the only full-genotyping test validated both for screening purposes and for self-sampling. Trial registration ASUGI Trieste n. 16008/2018; CRO Aviano n.17149/2018

Climate-smart agriculture involves practices and crop modelling techniques aiming to provide practical answers to meet growers’ demands. For viticulturists, early prediction of harvest dates is critical for the success of cultural practices, which should be based on accurate planning of the annual growing cycle. We developed a modelling tool to assess the sugar concentration levels in the Douro Superior sub-region of the Douro wine region, Portugal. Two main cultivars (cv. Touriga-Nacional and Touriga-Francesa) grown in five locations across this sub-region were studied. Grape berry sugar data, with concentrations between 170 and 230 g L−1, were analyzed for the growing season campaigns, from 2014–2020, as an indicator of grape ripeness conditioned by temperature factors. Field data were collected by ADVID (“Associação Desenvolvimento Da Viticultura Duriense”), a regional winemaker association, and by Sogrape, the leading wine company from Portugal. The “Phenology Modeling Platform” was used for calibrating the model with sigmoid functions. Subsequently, model optimizations were performed to achieve a harmonized model, suitable for all estates. Model performance was assessed through two metrics: root mean square error (RMSE) and the Nash–Sutcliffe coefficient of efficiency (EFF). Both a leave-one-out cross-validation and a validation with an independent dataset (for 1991–2013) were carried out. Overall, our findings demonstrate that the model calibration achieved an average EFF of 0.7 for all estates and sugar levels, with an average RMSE < 6 days. Model validation, at one estate for 15 years, achieved an R2 of 0.93 and an RMSE < 5. These models demonstrate that air temperature has a high predictive potential of sugar ripeness, and ultimately of the harvest dates. These models were then used to build a standalone easy-to-use computer application (GSCM—Grapevine Sugar Concentration Model), which will allow growers to better plan and manage their seasonal activities, thus being a potentially valuable decision support tool in viticulture and oenology.

Background/Objectives: The diagnosis of atypical endometrial hyperplasia (AEH) is associated with a high rate of concurrent endometrial cancer (EC). This occurrence can be particularly challenging in premenopausal women wishing to become pregnant, as they may be subjected to conservative treatment. The type of endometrial sampling may affect this outcome. Currently, the recommended type of endometrial sampling is under hysteroscopic guidance. There is scant literature regarding the reliability of hysteroscopically guided biopsy (HSC-bio) and hysteroscopic endometrial resection (HSC-res) on this topic. We aimed to assess the underestimation rate of EC in AEH, according to different hysteroscopic sampling methods. The secondary outcome was to evaluate the procedure performance in pre- and postmenopausal women. Methods: We conducted a multi-institutional retrospective study that included 536 women diagnosed with AEH who underwent hysterectomy between 2015 and 2020. Patients were divided into two groups based on the initial diagnostic approach for AEH: HSC-bio and HSC-res. The comparison was performed using univariate and multivariate analyses. Results: 160/536 women (29.9%) showed EC at hysterectomy. Overall, the following rate of EC underestimation was found: HSC-bio = 32.1%, HSC-res = 24.2%, p = 0.07. After adjusting for baseline characteristics using logistic regression analysis, overall, there was no significant association of EC underestimation according to the type of sampling procedure. Interestingly, in premenopausal women, including 161 cases, the rate of EC underestimation in HSC-bio and HSC-res was 28.8% vs. 14.0%, respectively (p = 0.034). Conclusions: There were no significant differences in EC underestimation between the two hysteroscopic procedures in the entire cohort of women with AEH. Limited to the secondary objective, the significant findings in premenopausal women may be of particular clinical interest, as this population may undergo conservative treatment.

The aim of this study was to investigate the effect of childbirth and breastfeeding on uterine fibroids and to identify the factors associated with size variations. This was a monocenter observational study carried on women with a sonographic diagnosis of uterine fibroids from January 2007 to December 2016, with no indication for immediate treatment, and who became pregnant within one year from diagnosis. All patients were re-evaluated six months after delivery. Fibroid diameters were compared between pre-pregnancy period, first, second, third trimester and post-delivery. The rate of “regressed” (growth of diameter <−40%), “unchanged” (growth of diameter between −40% and +40%) or “increased” (growth of diameter >+40%) fibroids at the post-delivery evaluation with respect to the pre-pregnancy state was calculated. One-hundred fifty-seven women were included in the final analysis. At the post-delivery ultrasound, a significant reduction of the fibroid diameter with respect to all previous examinations was observed, and there was no evidence of 67 (37.2%) fibroids. Ongoing breastfeeding was positively associated with an “unchanged” or “regressed” fibroid diameter (adOR 3.23, 95%CI: 1.35–7.70, p < 0.01). Smaller pre-gravidic fibroids were more likely to return to pre-pregnancy dimensions or to regress, with a cut-off of 32 mm for lactating women and of 26 mm for non-lactating women. In conclusion, fibroids seem to return to pre-pregnancy dimensions or to regress in the post-partum period. This process may be sustained by uterine involution and hormonal variations, with an additional role of breastfeeding.

ObjectiveTo evaluate the risk of progression to high-grade squamous intraepithelial lesion (HSIL) (CIN2-3) or invasive cancer in women with histopathological diagnosis of low-grade squamous intraepithelial lesion (LSIL) (CIN1), managed in a long-term observational approach up to 5 years.DesignRetrospective cohort study.SettingFour tertiary referral hospital.Participants434 women with adequate colposcopy and complete colposcopic charts were included in the present analysis. Women with glandular lesions on the referral cytology or previous diagnosis of cervical dysplasia or invasive cervical cancer or with synchronous vaginal, or with HIV infection or immunodepression were excluded.Primary and secondary outcome measuresThe main study outcome was the rate of progression to histopathological HSIL (CIN2-3) or invasive cancer at any time during 5 years of follow-up. The possible risk factors were also evaluated. As secondary outcome, we analysed the possible risk factors at the 24-month evaluation for histopathological HSIL (CIN2-3) or invasive cancer progression between 2 and 5 years from initial diagnosis.ResultsA progression to histopathological HSIL (CIN2-3) was found in a total of 32 (7.4%) cases during 5 years of follow-up. A histopathological diagnosis of HSIL (CIN3) was found in four patients (0.9%) and no case of invasive cancer was detected. High-grade cytology at inclusion and the presence of a positive high-risk human papillomavirus (HR-HPV) DNA test at 2 years from inclusion maintained a significant correlation with the risk of histopathological progression to HSIL (CIN2-3).ConclusionsThe results of our study showed a low rate (7.4%) of histopathological progression to HSIL (CIN2-3) in women with LSIL (CIN1) diagnosis during long-term follow-up up to 5 years. In case of positive HR-HPV DNA test at the 2 years evaluation an excisional treatment could be the preferred choice to prevent progression to HSIL (CIN2-3) in the following years, preferring a continuation of follow-up in case of HR-HPV DNA negative result.

PurposeLaparoscopic myomectomy is the uterus-preserving surgical approach of choice in case of symptomatic fibroids. However, it can be a difficult procedure even for an experienced surgeon and can result in excessive blood loss, prolonged operating time and postoperative complications. A combined approach with laparoscopic uterine artery occlusion and simultaneous myomectomy was proposed to reduce these complications. The aim of this study was to evaluate the safety and efficacy of the combined laparoscopic approach in women with symptomatic “large” intramural uterine fibroids, compared to the traditional laparoscopic myomectomy alone.MethodsProspective nonrandomized case–controlled study of women who underwent a conservative surgery for symptomatic “large” (≥ 5 cm in the largest diameter) intramural uterine fibroids. The “study group” consisted of women who underwent the combined approach (laparoscopic uterine artery bipolar coagulation and simultaneous myomectomy), while women who underwent the traditional laparoscopic myomectomy constituted the “control group”. A comparison between the two groups was performed, and several intraoperative and postoperative outcomes were evaluated.ResultsNo significant difference in the overall duration of surgery between women of the “study group” and “control group” emerged; however, a significantly shorter surgical time for myomectomy was observed in the “study group”. The intraoperative blood loss and the postoperative haemoglobin drop were significantly lower in the “study group”. No difference in the postoperative pain between groups emerged, and the postoperative hospital stay was similar in the two groups.ConclusionsThe laparoscopic uterine artery bipolar coagulation and simultaneous myomectomy is a safe and effective procedure, even in women with symptomatic “large” intramural uterine fibroids, with the benefit of a significant reduction in the intraoperative blood loss when compared to the traditional laparoscopic myomectomy.

Background Extra-mammary Paget’s disease of the vulva (EMPDV) is an infrequent chronic disease that often recurs. The aim of the study was to assess the presence of neoangiogenesis and the expression of epithelial-mesenchymal transition (EMT) markers in EMPDV, and their potential correlation with stromal invasion. Methods All the women consecutively treated for EMPDV at our Institute, between January 2011 and December 2014, were studied for neoangiogenesis, analysed by microvessel density (MVD) using antibodies against CD31 and CD34. Immunohistochemical expression of E- / N-cadherin, β-catenin and SLUG was also evaluated. In each slide, three fields with the highest number of capillaries and small venules were identified at low power. In these three fields, the highest vessel density (HVD) and the average vessel density (AVD) at 200× and 400× magnification were counted. Immunohistochemical reactions for non-vascular markers were semiquantitatively scored by two pathologists, using a three-tier scale. Results Seventeen cases of EMPDV (including 10 cases of invasive disease) were included. The AVD at 200× and 400× and the HVD at 400× magnification were significantly associated with invasive EMPDV ( p  = 0.02, 0.03, 0.03 respectively). No significant correlation between MVD, EMT-markers expression and risk of recurrence was detected. Conclusion These results indicate that MVD, as a measure of neoangiogenesis, may be associated with histological progression of EMPDV. EMT could also be linked to an invasive potential of EMPDV but larger series are required to confirm this hypothesis.

The objective of this study was to analyze the impact of cone characteristics (depth, transverse diameter, and volume) on subsequent pregnancies after the loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN 2–3). Pregnancy outcomes (preterm birth, gestational age at birth, mode of delivery, and birth weight) of 501 women with singleton gestations and no previous preterm birth or history of late miscarriage, who had previously undergone a single LEEP for CIN 2–3, were retrospectively analyzed with respect to length, transverse diameter, and volume of the excision specimen. The overall incidence of preterm birth was 2.4%. The rate of preterm birth in women with length greater than 20 mm or volume greater than 2.5 cm 3 was significantly higher than that in women with length between 15 and 19 mm (15.6 vs. 3.9%, P=0.02) or women with volume between 2.0 and 2.4 cm³ (5.8 vs. 1.6%, P=0.04). A linear inverse correlation (r=-0.3, P<0.001) between gestational age at birth and length, but not volume (r= 0.0,P=0.9) or transverse diameter (r=0.2, P<0.0001), emerged. The mode of delivery was not affected by cone characteristics. Length, but not transverse diameter and volume, of the excised specimen seems to be related to a lower gestational age at birth. When excisions are performed under strict colposcopic guidance, with a correct modulation of cone length, the risk for preterm birth and cesarean delivery in subsequent pregnancies is not increased.

It is unknown whether human papillomavirus (HPV) status impacts the prognosis of early stage cervical glandular lesions. This study assessed the recurrence and survival rates of in situ/microinvasive adenocarcinomas (AC) according to HPV status during a 5-year follow-up. The data were retrospectively analyzed in women with available HPV testing before treatment. One hundred and forty-eight consecutive women were analyzed. The number of HPV-negative cases was 24 (16.2%). The survival rate was 100% in all participants. The recurrence rate was 7.4% (11 cases, including four invasive lesions (2.7%)). Cox proportional hazards regression showed no difference in recurrence rate between HPV-positive and HPV-negative cases (p = 0.148). HPV genotyping, available for 76 women and including 9/11 recurrences, showed a higher relapse rate for HPV-18 than HPV-45 and HPV-16 (28.5%, 16.6%, and 9.52%, p = 0.046). In addition, 60% and 75% of in situ and invasive recurrences, respectively, were HPV-18 related. The present study showed that most ACs were positive for high-risk HPV, and the recurrence rate was unaffected by HPV status. More extensive studies could help evaluate whether HPV genotyping may be considered for recurrence risk stratification in HPV-positive cases.

Background: The rate of concurrent endometrial cancer (EC) in atypical endometrial hyperplasia (AEH) can be as high as 40%. Some patient characteristics showed associations with this occurrence. However, their real predictive power with related validation has yet to be discovered. The present study aimed to assess the performance of various models based on patient characteristics in predicting EC in women with AEH. Methods: This is a retrospective multi-institutional study including women with AEH undergoing definitive surgery. The women were divided according to the final histology (EC vs. no-EC). The available cases were divided into a training and validation set. Using k-fold cross-validation, we built many predictive models, including regressions and artificial neural networks (ANN). Results: A total of 193/629 women (30.7%) showed EC at hysterectomy. A total of 26/193 (13.4%) women showed high-risk EC. Regression and ANN models showed a prediction performance with a mean area under the curve of 0.65 and 0.75 on the validation set, respectively. Among the best prediction models, the most recurrent patient characteristics were age, body mass index, Lynch syndrome, diabetes, and previous breast cancer. None of these independent variables showed associations with high-risk diseases in women with EC. Conclusions: Patient characteristics did not show satisfactory performance in predicting EC in AEH. Risk stratification in AEH based mainly on patient characteristics may be clinically unsuitable.