Reports From Four International Clinical Trials for Cancers of the Cervix, Uterus and Vulva, and a New Guideline for Cervical Cancer

2021 ◽  
Vol 111 (2) ◽  
pp. 299-306
Author(s):  
Shari Damast ◽  
Emma Fields ◽  
Elizabeth Kidd ◽  
Matthew Harkenrider ◽  
Supriya Chopra ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Cervix Uterus

scholarly journals Cervical cancer vaccine development

Sexual Health ◽  
2010 ◽  
Vol 7 (3) ◽  
pp. 230 ◽  
Author(s):  
Ian H. Frazer
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Human Papillomavirus ◽  
Cancer Vaccine ◽  
Vaccine Development ◽  
Global Burden ◽  
Viral Capsids ◽  
Cervical Epithelium ◽  
Papillomavirus Vaccines ◽  
Cervical Cancer Vaccine

Cervical cancer is initiated by infection of cervical epithelium with human papillomavirus. Vaccines have been developed, incorporating papillomavirus viral capsids and alum based adjuvants. In extensive clinical trials these vaccines have been shown safe and effective in preventing infection with, and disease caused by, the papillomavirus genotypes they incorporate, in women not already infected. These vaccines have the potential to reduce the global burden of cervical cancer by up to 70%.

scholarly journals Active clinical trials of cervical cancer committee in KGOG

2021 ◽  
Author(s):  
Yong Wook Jung ◽  
Ju Won Roh ◽  
Kwang Beom Lee ◽  
Min-Hyun Baek ◽  
Ki Dong Kim ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials

scholarly journals Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Human Subjects ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Pragmatic Trials ◽  
Exclusion Criteria ◽  
Policy Makers ◽  
Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

Human papillomavirus (HPV) vaccination: from clinical studies to immunization programs

2019 ◽  
Vol 29 (8) ◽  
pp. 1317-1326 ◽  
Author(s):  
Raúl Murillo ◽  
Camila Ordóñez- Reyes
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Population Based ◽  
Immunization Programs ◽  
Hpv Vaccines ◽  
Middle Income ◽  
Middle Income Countries

Cervical cancer incidence and mortality have decreased in high-income countries, but low- and middle-income countries continue to bear a significant burden from the disease. Human papillomavirus (HPV) vaccines are a promising alternative for disease control; however, their introduction is slow in settings with greater need. We conducted a review of HPV vaccine efficacy and effectiveness reported in clinical trials and population-based studies. Efficacy of HPV vaccines is close to 100% when using a three-dose schedule in HPV-negative young women (<25 years old) for protection against persistent infection and HPV vaccine-type associated pre-cancerous lesions. Furthermore, sustained protection for up to 12 years of follow-up has been demonstrated; cross-protection against non-vaccine types is particularly observed for the bivalent vaccine, and preliminary data regarding impact on invasive cancer have emerged. Given its lower efficacy, catch-up vaccination beyond 19 years of age and proposals for vaccinating adult women deserve careful evaluation in accurately designed studies and economic analyses. Despite positive results regarding immunogenicity and post-hoc analysis for cervical intra-epithelial neoplasia in clinical trials, population-based data for prime and booster two-dose schedules are not available. Evaluation of vaccine safety from surveillance systems in immunization programs that have already distributed more than 270 million doses found no association of HPV vaccination with serious side effects. The introduction of HPV vaccination in national immunization programs remains the main challenge in tackling the burden of cervical cancer (up to 2018, only 89 countries have introduced vaccination worldwide, and most of these are high-income countries). Access models and technical capacity require further development to help low- and middle-income countries to increase the pace of vaccine delivery. Alternative approaches such as one-dose schedules and vaccination at younger ages may help reduce the programmatic and economic challenges to adolescent vaccination.

Risk Assessment Tool for Distant Recurrence After Platinum-Based Concurrent Chemoradiation in Patients With Locally Advanced Cervical Cancer: A Korean Gynecologic Oncology Group Study

2012 ◽  
Vol 30 (19) ◽  
pp. 2369-2374 ◽  
Author(s):  
Sokbom Kang ◽  
Byung-Ho Nam ◽  
Jeong-Yeol Park ◽  
Sang-Soo Seo ◽  
Sang-Young Ryu ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Fdg Pet ◽  
Locally Advanced ◽  
Distant Recurrence ◽  
Competing Risk ◽  
Advanced Cervical Cancer ◽  
Concordance Index ◽  
Good Discrimination ◽  
Locally Advanced Cervical Cancer

Purpose Our study aimed to develop a model to predict distant recurrence in locally advanced cervical cancer, which can be used to select high-risk patients in enriched clinical trials. Patients and Methods Our study was a retrospective analysis of a multi-institutional cohort of patients treated between 2001 and 2009. According to the order of data submission, data from three institutions were allocated to a model development cohort (n = 434), and data from the remaining two institutions were allocated to an external validation cohort (n = 115). Patient information including [18F]fluorodeoxyglucose positron emission tomography (FDG-PET) data and clinical outcome was modeled using competing risk regression analysis to predict 5-year cumulative incidence of distant recurrence. Results The competing risk analysis revealed that the following four parameters were significantly associated with distant recurrence: pelvic and para-aortic nodal positivity on FDG-PET, nonsquamous cell histology, and pretreatment serum squamous cell carcinoma antigen levels. This four-parameter model showed good discrimination and calibration, with a bootstrap-adjusted concordance index of 0.70. Also, the validation set showed good discrimination with a bootstrap-adjusted concordance index of 0.73. A user-friendly Web-based nomogram predicting 5-year probability of distant recurrence was developed. Conclusion We have developed a robust model to predict the risk of distant recurrence in patients with locally advanced cervical cancer. Further, we discussed how the selective enrichment of the patient population could facilitate clinical trials of systemic chemotherapy in locally advanced cervical cancer.

The power of the biomarker for cervical cancer control

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 11001-11001
Author(s):  
N. S. Markovic ◽  
O. Markovic ◽  
E. S. Henderson
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Pap Smear ◽  
Digital Images ◽  
Papanicolaou Test ◽  
New Device ◽  
Comparison Results ◽  
Digital Evaluation ◽  
In Vitro Diagnostic

11001 Background: At ASCO 2001, the Cervical Acid Phosphatase - Papanicolaou Test (CPT) was introduced as a biomarker-based technology as a potential in vitro diagnostic device. At ASCO 2004 and 2005, we reported results from clinical trials on 2,000 subject/specimens. In a setting of standard cervical cancer screening, the safety and effectiveness of CPT (MarkPap® Test) was compared with control Pap smear and LBP. The favorable results motivated us to expand this translational research in areas where this biomarker is crucial: self-sampling and digital evaluation. We report a pilot study designed to assess whether upgrading CPT with digital image processing (IT technology) could create a new device for an effective telecytopathology. Methods: Material: Cervical specimens self-obtained by volunteers, specimens collected in prior clinical trials (Library of MarkPap slides), and control slides. Instruments and methods: We have assembled a set of instruments and procedures to create images from microscopic slides, to convert analog into digital images, to capture and store digital images and clinical data in computer files, to transfer image files via Internet to a central server for evaluation by cytotechnologist/pathologists, and to return the reports within hours. At the end, the results of reading digital and direct images were available for comparison. Results: Since each instrument was “fit-for-use”, we have tested different “conditions-for-use” for providing digital images comparable to direct images. Images of self-sampled specimens, controls and existing slides were processed through a new setup of five modules: image acquisition, image and data transferring, image evaluation, results reporting and quality control. It was made possible by upgrading software. There was no difference between results obtained after evaluation of digital or direct images. Conclusion: Using CPT and available instruments and software, we have developed a prototype in vitro diagnostic medical device, which could permit expert evaluation of cervical specimens to be performed rapidly and at affordable cost for developing countries. This device should be able to use self-obtained specimens, field laboratory personnel and equipment, but to provide high-qualified evaluation within hours for an easy affordable cost. [Table: see text]

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