Active clinical trials for "Uterine Cervical Dysplasia"

This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and High risk groups for the purpose of determining whether they require enhanced colposcopy and additional biopsies in order to increase detection of CIN2+ cervical disease.

Cervical cancer is the fourth most common cancer in women worldwide. It is caused by an infection with human papillomavirus (HPV). A persistent infection with HPV is associated with increased risk of precancerous lesions, which may further develop into cervical cancer. To reduce the disease burden, accurate and timely diagnosis of cervical precancerous lesions are crucial. To identify cervical precancerous lesions, women are referred to colposcopy, which is the most important diagnostic tools to detect cervical precancerous lesions. It allows close visualization of the cervix in order to collect biopsies in the area called transformation zone (TZ), which is where precancerous lesions develop. It is essential for the physician to identify the TZ during colposcopy in order to obtain correct diagnosis. For women aged ≥50 this is often a challenge as TZ naturally with age, will retract further into the cervical canal, making the area for sampling invisible, and thereby the colposcopy inadequate. Consequently, this increases the risk of developing cancer due to diagnostic delay, and the risk of several colposcopy examinations or overtreatment (cone biopsy), before a final diagnosis is achieved. Few studies suggest that pretreatment with local vaginal estrogen prior to colposcopy may improve visualization of the TZ. Thereby, obtaining more accurate biopsies from the cervix, and thus making a more accurate and timely diagnosis in the first outpatient visit. The primary purpose of this study is to evaluate pre-diagnostic treatment with estrogen to improve the diagnosis of women with cervical precancerous lesions, in order to prevent cervical cancer. The study ia s randomized controlled double-blinded multicenter study. The investigators will use information from Danish National Patient registry, and data from the Danish Pathology Data Bank. Enrollment will take place at the Departments of Gynecology in Denmark. Eligible women aged ≥ 50 years will be randomized 1:1 to receive local vaginal estrogen or placebo prior to the colposcopic examination. The investigators believe the results will provide the prerequisite for obtaining correct diagnosis, and thereby provide basis for choosing the right individualized examination- and treatment plan. The results will also contribute with important knowledge, that may help reduce the incidence and mortality rate of cervical cancer.

Background: Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names. Objective: To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects. Eligibility: People aged 18 and older who have had gene therapy in a National Cancer Institute study Design: Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are. For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers. For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples. When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy. ...

The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other words, can the investigators detect the high risk strains of the human papilloma virus (HPV) that are associated with cervical cancer in self-collected menstrual blood, as an alternative to collecting vaginal swabs.

This study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.

The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.

In this study, the investigators will prospectively collect, analyze and integrate information regarding vaginal microbiome composition and HPV presence in women with cervical pathologies (high-grade CIN and CC) and controls, to construct a large dataset from patients with pre-cancerous cervical lesions and healthy women, to evaluate the personalized contribution of the vaginal microbiome to the CIN-CC sequence.

The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma. This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in tampon-collected vaginal fluid and 2) ovarian cancer (OC) in plasma and tampon-collected vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.

The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.