Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment
Anal CancerSexuality3 moreThe purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis.
Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex...
Anal CarcinomaHIV Infection1 moreThis clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers...
HPV-Associated Cervical CarcinomaHPV-Related Carcinoma15 moreThe goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival. This study seeks to determine 1) if E7 TCR-T cell can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, 3) and the disease-free survival rate at 2 and 5 years. Participants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.
Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Anal CancerAnal Carcinoma1 moreA single-arm, prospective, Phase II, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related GI toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)
WartsGenital2 moreThe purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.
Detecting HPV DNA in Anal and Cervical Cancers
Cervical CancerAnal Cancer4 moreThis is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Anal CancerA commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of <20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of >35-49% as Grade 3 and a reduction >/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.
Anal Intraepithelial Neoplasia and Anal Squamous Cell Carcinoma
Anal CancerAnal Squamous Intraepithelial NeoplasiaThis is a study involving exome sequencing and immune profiling of matched tissue and blood samples from patients with both high-grade squamous intraepithelial lesions and anal squamous cell carcinoma. This is a collaborative project between Imperial College London and the Institute of Cancer Research (ICR), investigating the genetic predeterminants for the progression of anal HSIL to SCC as well as the immunogenetic profile of these conditions will be beneficial for risk stratification (with respect to identifying those individuals with anal HSIL most likely to progress to invasive disease), the identification of potential new drug targets and will add to our understanding of how the tumour microenvironment may influence treatment response and disease recurrence of both anal HSIL and SCC.
Adaptive Radiation in Anal Cancer
Anal Squamous Cell CarcinomaThis is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.
HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL
Anal Intraepithelial NeoplasiaAnal Cancer1 moreHuman papillomavirus (HPV) is the most common sexually transmitted infection (STI) worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal infection with these HR-HPV strains, and the resultant high-grade anal dysplasia and anal cancer are much higher in men who have sex with men (MSM) than in the general population. Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer prior to the adoption of routine cervical cytology screening. Despite these alarming statistics, there are no established protocols for optimal screening and treatment of anal HPV and cancer precursors, nor has there been any widespread rollout of organized screening programs anywhere in Canada. Further, not only does HPV directly cause significant disease in these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies in care for HIV-positive MSM. The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team was funded by the Canadian Institutes of Health Research (CIHR) via its Boys' and Men's Health Team Grant Competition. It aims to recruit a large group of MSM from various Ontario and Vancouver clinics, in order to carry out a number of different studies. The HPV-SAVE team brings together community and internationally-recognized experts in HPV and HIV disease and mucosal immunology, to better define the optimal approaches for primary and secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor for HIV transmission. This will yield critical information which can lead to improvement in the health of MSM, and will provide a foundation on which to build large-scale screening and treatment trials on a national level. A key part of this research program involves an analysis of the potential role played by the HPV vaccine in the overall management of HIV-positive MSM. Planned vaccine-related projects include: A mixed-methods analysis of the knowledge, attitudes, and acceptability of HPV vaccination amongst HIV-positive MSM, through quantitative (e.g. cross-sectional survey) and qualitative (e.g. in-depth interviews) means. A comprehensive assessment of the 9-valent HPV vaccine in HIV-positive MSM, including safety and immunogenicity, as well as its potential role in secondary prevention of high-grade anal dysplasia. This is the study on which the current proposal is based.