The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams
Uterine Cervical DysplasiaUterine Cervix CancerThis study is intended to improve the patient experience of communication of colposcopy results and follow-up recommendations to patients. Current practice involves results being forwarded from the colposcopy clinic to the family or referring physician who then informs the patient. We are testing an intervention informed by focus groups in which a trained colposcopy nurse (patient liaison) directly contacts patients with their results and follow-up recommendations while providing education and support. We will examine whether this intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence to follow-up and treatment appointments compared to the current practice.
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
Uterine Cervical NeoplasmUterine Neoplasms13 moreThe Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate effectiveness of home-based HPV kits for improving cervical cancer screening uptake and its cost-effectiveness. The investigators will compare cervical cancer screening uptake within six months among women randomized to different outreach approaches based on prior screening behavior: A) Adherent and coming due: direct mail HPV kit vs. opt-in HPV kit vs. education; B) Overdue: direct mail HPV kit vs. education; C) Unknown: opt-in HPV kit vs. education.
FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program
Cervical Intraepithelial NeoplasiaHPV-Related Cervical CarcinomaObjective. To evaluate the impact of HPV vaccination as part of a hrHPV-based primary screening program to extend screening intervals. Materials and methods. A total of 3,000 women aged 25-45 years, attending the regular cervical cancer-screening program in primary health care services in Tlalpan, Mexico City, will be invited to the study. Eligible participants will be assigned to one of three comparison groups: 1) HPV16/18 vaccine and hrHPV-based screening; 2) HPV6/11/16/18 vaccine and hrHPV-based screening; 3) Control group who will receive only hrHPV-based screening. Strict surveillance of hrHPV persistent infection and occurrence of precancerous lesions will be conducted to estimate safety profiles at different screening intervals; participants will undergo diagnosis confirmation and treatment as necessary. Discussion: The FASTER-Tlalpan Study will provide insights into new approaches of cervical cancer prevention programs. It will offer valuable information on potential benefits of combining HPV vaccination and hrHPV-based screening to safety extend screening intervals.
Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia...
Cervical AbnormalitiesCervical Intraepithelial Neoplasia Grade 2/31 moreCervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting.
Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model
Cervical DysplasiaIn a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone (LLETZ) on a Training model afte having undergone a Video Training session. Their LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol designed for judging the surgical proficiency when performing a LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.
Imiquimod Treatment of Residual or Recurrent CIN Lesions: a Study Protocol
Cervical Intraepithelial NeoplasiaThe purpose of this study is to investigate if imiquimod can be used as a non-invasive option in the treatment of residual/recurrent CIN lesions.
Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)...
Cervical Intraepithelial NeoplasiaThe purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)
Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
Cervical Intraepithelial NeoplasiaThe purpose of this study is to determine the safety, feasibility, and regression rate of using curcumin in patients with Cervical Intraepithelial neoplasias (CIN3). The secondary objectives of this study is to evaluate patients with CIN3 for the presence of high-risk Human papillomavirus (HPV) and to perform an inflammatory panel on dysplasia biopsies from patients with CIN3 to determine which factors play a role in persistence of CIN3.
Digital Imaging Aid for Assessment of Cervical Dysplasia
Cervical DysplasiaThe overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix. The specific aims of the study are: To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue. To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix. To analyze digital images to determine which types of optical information yield the most diagnostically useful data.
A Efficacy and Safety Study of Composite Gel Containing Black Raspberry Extract in Removing HPV...
Cervical Intraepithelial NeoplasiaHPVTo evaluate the efficacy and safety of composite gel containing black raspberry extract in removing HPV From patients With cervical intraepithelial neoplasia(CIN) after cervical conization