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Cervical Intraepithelial Neoplasia clinical trials

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NCT ID: NCT03105856 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program

FASTER
Start date: January 3, 2017
Phase: Phase 4
Study type: Interventional

Objective. 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.

NCT ID: NCT03052556 Completed - Cystic Fibrosis Clinical Trials

Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis

MUCOHPV
Start date: March 8, 2017
Phase: N/A
Study type: Interventional

Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV), with several intermediate steps between HPV infection and cervical cancer. Cervical screening with pap smear test and HPV vaccination are effective preventions. A high frequency of HPV carriage and of cervical dysplasia have been described in transplanted women. The majority of women with cystic fibrosis reach adulthood and some will face transplantation. Particular attention should therefore be paid to cervical screening. However, low adherence to screening recommendations was noted. In addition, preliminary data has found a high frequency of abnormal smears and of inflammatory aspect of the cervix in women with cystic fibrosis. Objectives of the study The main objective of the study is to determine the prevalence of HPV carriage in a cohort of women with cystic fibrosis The secondary objectives are: - To study the factors associated with the prevalence of HPV (transplantation, smoking, age at first intercourse, number of sexual partners in the year, contraception, gravidity and parity, HPV vaccination) - To describe and to compare with data in the general population, in hospital-based population, (and with data in transplanted population for transplanted women) 1. the prevalence of HPV (and of different genotypes) infection, of cervical dysplasia, of vulvar/vaginal/cervical condylomatosis 2. the rate of HPV persistence (> 12 months), the mean time of HPV clearance; rates of spontaneous regression / persistence / worsening of cervical dysplasia Study design: The study will last 24 months. Includable patients are adult women, transplanted or not, followed at Lyon CRCM. Included women will attend a consultation with a gynaecologist. Pap smear test (liquid phase cytology) and genomic DNA microarray assay enabling the detection of 35 different HPV genotypes will be performed. Patients with an initial abnormal pap smear or a positive HPV test will be monitored: - In case of an abnormal smear and / or positive HPV test, pap smear and HPV testing will be renewed every 6 months during the study period - In case of an abnormal smear: Atypical squamous cells of undetermined significance (ASC-US) : the attitude will depend on the result of the HPV test Atypical squamous cells - cannot exclude HSI L (ASC-H), Low-grade squamous intraepithelial lesion (LSIL), High-grade squamous intraepithelial lesion (HSIL), Atypical glandular cell of undetermined significance (AGUS) , Atypical glandular cells (AGC) , Adenoma carcinoma in situ (AIS), carcinoma: a colposcopy will be systematically performed Expected results This study will help to determine the frequency of HPV infection and the pathogenic power of HPV in non-transplanted and in transplanted women with cystic fibrosis This data will help to sensitize health professionals on the importance of gynecological care and regular cervical screening, and on the importance of HPV vaccination. In case of a high frequency of genital diseases linked to HPV, recommendations on gynecological monitoring procedures for women with cystic fibrosis could evolve.

NCT ID: NCT03005795 Completed - Clinical trials for Uterine Cervical Dysplasia

Music and Colposcopy in Women With Cervical Dysplasia.

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

To assess the effect of music during colposcopy on women´s anxiety.

NCT ID: NCT02986867 Completed - Melanoma Clinical Trials

SAbR Induced Innate Immunity in Urothelial Carcinoma, Melanoma, and Cervical Carcinoma

Start date: June 13, 2017
Phase: N/A
Study type: Interventional

The study is an exploratory prospective, single center study with correlative endpoints. The study will investigate the association of tumor cGAS STING signaling with SAbR. Tumor core biopsies will be processed and analyzed as described above. Medical records electronic medical records will be used to collect demographic and medical information and imaging studies.

NCT ID: NCT02934724 Completed - Cervical Cancer Clinical Trials

Impact of HPV Vaccine On The Prevalence Of HPV In Norway

Start date: November 2016
Phase:
Study type: Observational

The overall aim of the study is to assess the effect of school-based Human Papillomavirus (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year of vaccine initiation of the 1997-cohort) are invited to participate in the study.

NCT ID: NCT02910388 Completed - Clinical trials for Uterine Cervical Dysplasia

LLETZ Under Direct Colposcopic Vision

Start date: October 2016
Phase: N/A
Study type: Interventional

To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.

NCT ID: NCT02907333 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia

Start date: September 2016
Phase: N/A
Study type: Interventional

Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 6 months after the diagnosis with new examinations. The regression rate is based solely on the woman's own ability to clear the cervical lesions. The use of condoms has shown a relatively good protective effect against Human Papillomavirus (HPV) infection. It has furthermore been indicated that condoms increase the regression rate of cervical lesions. The hypothesis of this study is that the regression rate of cervical intraepithelial neoplasia grade 2 (CIN2) increases when condoms are used consistently in the follow-up period of 6 months.

NCT ID: NCT02864147 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)

Start date: July 2016
Phase: Phase 2
Study type: Interventional

This is a randomized Phase II, three arm control trial in patients with Cervical Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3 meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study pathologist to confirm diagnosis. HPV DNA test and HPV 16/18 genotyping will be performed from endocervical cytobrush samples to determine HPV status associated with the dysplasia. Patients who have CIN 2/3 with HPV+ disease will be enrolled in this study. Patients will be randomized to one of three arms: observation only (control), imiquimod only, imiquimod + 9-valent HPV vaccine.

NCT ID: NCT02814448 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

An Innovative Treatment for Cervical Pre Cancer

CryoPen
Start date: February 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.

NCT ID: NCT02811367 Completed - Clinical trials for Human Papilloma Virus Infection

The HPV Self-test as a Test of Cure in Madagascar

Start date: June 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.