23 Clinical Trials for Various Conditions
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
HPV-Related Anal Intraepithelial Neoplasia, AIN2/3, Artesunate, Alternative Treatment, Anal Dysplasia, Precancerous Conditions, Human Papilloma Virus
This 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.
Anal Carcinoma, HIV Infection, Human Papillomavirus Infection
This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of patients with pre-malignant tumors and superficial microinvasive disease of the anal canal and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer ALA orally followed by the administration of red light (629-635 nm) to the tumor from a laser. The dose of ALA will be 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients in each. Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT. Patients will be observed for 30 days for the development of DLT. Patients will be followed up for 24 months for additional toxicity and efficacy data collection.
Anal Dysplasia, Carcinoma in Situ
This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.
Cervical Adenocarcinoma, Cervical Adenocarcinoma in Situ, Cervical Intraepithelial Neoplasia, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Cervical Squamous Intraepithelial Neoplasia, Early Invasive Cervical Adenocarcinoma, Early Invasive Cervical Squamous Cell Carcinoma, High Grade Cervical Squamous Intraepithelial Neoplasia, High Grade Vaginal Intraepithelial Neoplasia, Low Grade Vaginal Intraepithelial Neoplasia, Stage I Cervical Cancer AJCC V8, Stage I Vaginal Cancer AJCC V8, Stage I Vulvar Cancer AJCC V8, Stage IA Cervical Cancer AJCC V8, Stage IA Vaginal Cancer AJCC V8, Stage IA Vulvar Cancer AJCC V8, Stage IA1 Cervical Cancer AJCC V8, Stage IA2 Cervical Cancer AJCC V8, Stage IB Cervical Cancer AJCC V8, Stage IB Vaginal Cancer AJCC V8, Stage IB Vulvar Cancer AJCC V8, Stage IB1 Cervical Cancer AJCC V8, Stage IB2 Cervical Cancer AJCC V8, Stage II Cervical Cancer AJCC V8, Stage II Vaginal Cancer AJCC V8, Stage II Vulvar Cancer AJCC V8, Stage IIA Cervical Cancer AJCC V8, Stage IIA Vaginal Cancer AJCC V8, Stage IIA1 Cervical Cancer AJCC V8, Stage IIA2 Cervical Cancer AJCC V8, Stage IIB Cervical Cancer AJCC V8, Stage IIB Vaginal Cancer AJCC V8, Stage III Cervical Cancer AJCC V8, Stage III Vaginal Cancer AJCC V8, Stage III Vulvar Cancer AJCC V8, Stage IIIA Cervical Cancer AJCC V8, Stage IIIA Vulvar Cancer AJCC V8, Stage IIIB Cervical Cancer AJCC V8, Stage IIIB Vulvar Cancer AJCC V8, Stage IIIC Vulvar Cancer AJCC V8, Stage IV Cervical Cancer AJCC V8, Stage IV Vaginal Cancer AJCC V8, Stage IV Vulvar Cancer AJCC V8, Stage IVA Cervical Cancer AJCC V8, Stage IVA Vaginal Cancer AJCC V8, Stage IVA Vulvar Cancer AJCC V8, Stage IVB Cervical Cancer AJCC V8, Stage IVB Vaginal Cancer AJCC V8, Stage IVB Vulvar Cancer AJCC V8, Vaginal Adenocarcinoma, Vulvar Adenocarcinoma, Vulvar High Grade Squamous Intraepithelial Lesion, Vulvar Intraepithelial Neoplasia, Vulvar Squamous Cell Carcinoma, Vulvar Squamous Intraepithelial Lesion
This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.
Anal Squamous Intraepithelial Lesion (ASIL), HPV DNA
Context: Men who have sex with men (MSM) are at increased risk for HPV-related anal neoplasia and anal squamous cell carcinoma; concomitant HIV infection roughly doubles that risk. Objectives: 1. To compare the efficacy of ablative therapy to topical imiquimod therapy in the management of anal dysplasia in HIV-infected men. 2. To describe relationship between cytologic grade of anal dysplasia (as reported on screening anal Pap test) and pathologic grade reported on anal mucosa histopathologic examination. 3. To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of anal dysplasia. 4. To describe adverse effects associated with ablative therapy and topical imiquimod therapy. Design: Prospective, randomized controlled clinical trial. This will be a pilot study. All subjects will undergo baseline anal Pap, HRA with biopsies as indicated, and anal HPV testing. If AIN 2 or 3 is discovered on histopathologic examination, subject will be offered observation only or treatment. If he chooses treatment, he will be randomized to: 1) imiquimod anal suppositories three times weekly for 3 months, or 2) appropriate ablative therapy as determined by colorectal surgeon. During imiquimod treatment (not applicable to ablative group as their treatment will be completed in one visit) subjects will be followed for 2 weeks, 4 weeks, 8 weeks, and 12 weeks with anal Pap, HRA with biopsies as indicated, and anal HPV testing. After therapy completed in each treatment group, subjects will be followed for 1 month, 3 months, 6 months, 9 months, and 12 months post-therapy with anal Pap, HRA with biopsies as indicated, and anal HPV testing. Observation only subjects will be evaluated every 3 months with anal Pap, HRA with biopsies as indicated, and anal HPV testing for 12 months. We have chosen a goal of 30 subjects in each treatment group and 10 subjects in the observation only group based on the likelihood of enrolling a study of this type in a reasonable amount of time. Main Outcome Measures: 1. Anal Pap cytologic grade, including regression and recurrence during course of study 2. HPV type in anal canal, including regression and recurrence during course of study 3. Anal histology, including regression and recurrence during course of study 4. Adverse effects experienced during treatment, recorded in symptom log
Anal Dysplasia, Human Papilloma Virus, HIV
The rationale for this study is that the risk of anal dysplasia in patients with inflammatory bowel disease (IBD) as compared to the general population has yet to be investigated prospectively. There have only been a few articles examining this relationship - preliminary results have suggested that patients with IBD are at increased risk for abnormal anal pap smears. As high grade anal dysplasia is strongly associated with an increased risk of anal carcinoma, it is important to identify all high risk groups that might benefit from routine screening. This pilot study aims to determine whether patients with IBD in our Bronx population have an increased risk of abnormal anal Pap smears. We hypothesize that there will be an increased incidence of abnormal anal pap smears in patients with IBD who have been treated with immunosuppressants, given that chronic immunosuppression is related to increased HPV infection.
IBD
The purpose of this research is to assess the safety and effectiveness of circumferential radiofrequency ablation (RFA) to the anal canal using the BarrxTM Ablation System to destroy anal high-grade squamous intraepithelial lesions (HSIL). The BarrxTM Ablation System used in this study comprises an RFA generator (Barrx™ FLEX) and the BarrxTM Anorectal Wand. The generator and wand are cleared by the Food and Drug Administration (FDA) for human use and the wand is specifically cleared for treatment of anal intraepithelial neoplasia (AIN). AIN is a precancerous condition. HSIL is an advanced form of AIN. The presence of HSIL has traditionally warranted treatment. RFA has been shown in many studies to effectively and safely destroy precancerous cells in a condition called Barrett's esophagus, which is a precancerous condition of the esophagus (the swallowing tube). Recent studies have shown that RFA may offer the same benefits for those with HSIL in the anal canal. In particular, ablation of the entire circumference of the canal seems to reduce recurrence of HSIL in other locations of the anal canal. This study will last between 12 to 15 months. Subjects will be required to undergo 5 to 8 study visits as outlined below that are carried out by the study doctors or the physician assistant. Most visits will last approximately one hour. Some may be shorter and some may be longer. Up to seventy (70) volunteers will participate in this study at several locations.
HSIL, High Grade Squamous Intraepithelial Lesions, Anal Cancer, HPV-Related Squamous Cell Carcinoma, Human Papilloma Virus, Human Papillomavirus Infection, Ain III
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN). Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA will be applied using the Barrx™ Ablation System.
Anal Intraepithelial Neoplasia (AIN), High-grade Squamous Intraepithelial Lesions (HSIL)
This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention will demonstrate that a reasonable proportion of subjects will be histologically cleared of their anal HSIL within the ETZ in a tolerable and relatively safe manner
HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood.
Anal Dysplasia
This study is being done to assess the safety of lopinavir/ritonavir in patients with PLWH with AIN. 30 participants will be recruited and can expect to be on active study for approximately 3 months and long term follow up for 40 weeks.
High-Grade Anal Intraepithelial Neoplasia
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions.
Anal Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Neoplasia, HIV Positivity, Human Papillomavirus-16 Positive, Human Papillomavirus-18 Positive
This randomized phase III trial studies imiquimod or fluorouracil to see how well they work compared to observation in treating patients with high-grade anal squamous skin lesions who are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether imiquimod or fluorouracil is more effective than observation in treating high-grade anal squamous skin lesions.
Anal Intraepithelial Neoplasia, High-grade Squamous Intraepithelial Lesion, HIV Infection
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).
Human Papilloma Virus, Anal Dysplasia, HIV
This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition, AIN 2/3, HPV Infection, Anal Dysplasia, HPV Disease
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.
Colon Polyps, Colonic Dysplasia, Anal Dysplasia
This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.
Anal Canal HPV Infection Diagnosis, Anal Dysplasia Diagnosis, Anal Cancer
The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are: * The maximum tolerated dose of ACU-D1 * Safety and tolerability of topical ACU-D1 * Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions * Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals Participants will be asked * To apply ACU-D1 on the lesions twice daily for 4 weeks * 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.
Human Papilloma Virus, Human Immunodeficiency Virus, Anal Intraepithelial Neoplasia, High-Grade Squamous Intraepithelial Lesions
The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection. The secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV. The clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.
Papillomavirus Vaccines, Human Immunodeficiency Virus, Papillomavirus Infection, Serology, Cervical Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Oral Cavity Infection
This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.
Anal Neoplasm
The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).
Anus Neoplasms
The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.
Pancreatic Cancer, Thyroid Cancer, Lung Cancer, Esophageal Cancer, Thymus Cancer, Colon Cancer, Rectal Cancer, Gastrointestinal Stromal Tumors, Anal Cancer, Bile Duct Cancer, Duodenal Cancer, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Small Intestine Cancer, Peritoneal Surface Malignancies, Familial Adenomatous Polyposis, Lynch Syndrome, Bladder Cancer, Kidney Cancer, Penile Cancer, Prostate Cancer, Testicular Cancer, Ureter Cancer, Urethral Cancer, Hypopharyngeal Cancer, Laryngeal Cancer, Lip Cancer, Oral Cavity Cancer, Nasopharyngeal Cancer, Oropharyngeal Cancer, Paranasal Sinus Cancer, Nasal Cavity Cancer, Salivary Gland Cancer, Skin Cancer, Central Nervous System Tumor, Central Nervous System Cancer, Mesothelioma, Breast Cancer, Leukemia, Melanoma, Sarcoma, Unknown Primary Tumor, Multiple Myeloma, Ovarian Cancer, Endometrial Cancer, Vaginal Cancer, Neuroendocrine Tumors, Plasma Cell Dyscrasia, Healthy Control