A Trial for Patients With Advanced/Recurrent Cervical Cancer
Cervical Intraepithelial NeoplasiaUterine Neoplasms2 moreThis phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.
Expectancy as Alternative to Treatment for Cervical Intraepithelial Neoplasia Grade 2 Among Women...
CIN2TherapyIn the Swedish organised cervical screening program precursors of cervical cancer are detected and treated. Most precursor lesions detected by screening heal spontaneously. Those who progress do it slowly. There are three levels from light; CIN1, moderate; CIN2 to severe; CIN3. Women with CIN3 are always treated, regardless of age, according to current clinical guidelines. Women with CIN2 who are below the age of 25 years are offered active expectance for up to two years because there is good evidence that they will spontaneously heal their lesions (regression) in 40-70% of the cases during that time. Method of treatment is today an excisional procedure of the cervix most often by Large loop excision of the transformation zone (LLETZ/LEEP) Treatment increases the risk of premature birth in a future pregnancy. In 2015 about 1800 excisional procedures of the transformation zone of the cervix were performed in the Västra Götalands regionen (VGR) om Sweden. The average age of first-time mothers in Sweden is rising and in 2014 it was 29 years. Postponed childbearing raises the question whether it is possible to refrain from surgery even for the group of women over 25 years old, with proven CIN2. Existing studies suggest that cure of CIN2 in the age group of and above 25 takes place in the same extent as under 25 years of age.There is lack of evidence concerning clinical follow-up. In a prospective multicenter clinical cohort study (observational study) with careful monitoring, the investigators will examine what proportion of CIN2 changes regress spontaneously within two years in women, 25-30 years old, and if human papillomavirus (HPV) type 16 may can be a marker for poor regression in this group. Instead of LLETZ, active expectance is offered to women this age with CIN2 in five gynecological clinics in VGR. The study protocol includes gynecologist visits every 6 months for two years, including cytology, colposcopy and directed biopsies of the cervix. Power calculation shows 160 women needs to be included, which is expected to occur within one year from the start.
Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
Cervical Intraepithelial NeoplasiaCervical DysplasiaThis 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.
Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
Uterine Cervical DysplasiaLoop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several methods have been proposed to reducing pain including submucosal block, paracervical block, and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine appeared to be the most common methods used. However, from the investigators experience, there is significant pain associated with the injection itself. Lidocaine spray is an effective measure for pain control during minor gastrointestinal and otolaryngological procedures. It is simple without pain related to application. An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine submucosal injection by comparing pain scores at various stages of the LEEP procedure.
An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical...
High-grade Cervical Intraepithelial NeoplasiaThis is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.
A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated...
Cervical Intraepithelial NeoplasiaThis randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.
Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion
Cervical Intraepithelial NeoplasiaThe purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease. SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to LLETZ cone, which is performed with a large loop electrode.
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
Cervical DysplasiaThe study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).
A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of...
Uterine Cervical DysplasiaThe purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.
Impact of AV2 Antiviral Drug on the Treatment of HPV-associated Lesions of the Uterine Cervix
Uterine Cervical DysplasiaPapillomavirus InfectionsIntroduction Cervical cancer (CC) is a major public health problem in Low-income countries (LICs), particularly in the Democratic Republic of the Congo (DRC), where the estimated number of cases is 3839 per year. (WHO, 2010). Persistent infection with Human Papillomavirus (HPV) is recognized as the necessary cause for the development of CC. Thus, CC is a disease that is easily preventable primarily by vaccination against HPV and secondarily through screening and treatment of precancerous lesions of the cervix. In LICs, the high incidence of CC is due to both high rates of infection with HPV, a failure to initiate and sustain effective screening programs based on cytology and the non-availability of vaccination against HPV. These situations highlight the need to implement simple and inexpensive screening and treatment methods suitable for LICs. These methods include screening by visual inspection of the cervix after application of acetic acid (VIA) and treatment with a topical antiviral drug (AV2). Aims This study aims to: Evaluate the clinical efficacy of AV2 as a treatment for HPV-associated lesions of the uterine cervix; Identify HPV genotypes found in Kinshasa; Determine the cost-effectiveness of an algorithm combining screening by VIA and AV2 and that combining VIA and cryotherapy treatment; Methods After basic training of local health workers on VIA, on collection of cervical samples for HPV testing (quantitative Polymerase Chain reaction, qPCR) and liquid-based cytology (LBC) and on application of AV2, a screening and treatment program will be offered to women aged 25 and older who will give their informed consent. All women with lesions on VIA will be randomized into one of two groups to receive either treatment by AV2 or placebo. All women with lesions on VIA will be monitored and reviewed after two months and after six months for repeat tests (VIA and LBC for lesions, qPCR for viral load, conversion and reinfection rates).