Clinical trials: Anal Intraepithelial Neoplasia
Neoplasms, Squamous Cell, Papillomavirus Infections
Modeling Study to Predict Progression of Anal Cancer Pre-cursor Lesions in HIV
The purpose of this study is to determine whether a model can be created to predict the progression of early anal cancer precursor lesions in HIV using potential predictors such as: HIV treatment history, smoking history, sexual…
- Trial name
- NCT01709448
- Where
- 2 sites in United States
- Volunteers
- 165 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.
- Conditions
- HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer
- Trial name
- NCT03202992
- Testing
- ABI-1968
- Where
- 6 sites in United States, Australia
- Volunteers
- 57 people
- Sponsor
- Antiva Biosciences
Anus Neoplasms, HIV Infections
Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
The purpose of this study is to assess if argon plasma coagulation (APC) is a safe and well tolerated treatment method for anal intraepithelial neoplasia (AIN) grade 2/3 in HIV-positive men having sex with men (MSM).
- Trial name
- NCT00428285
- Testing
- Argon Plasma Coagulation
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Squamous Intraepithelial Lesions, Laser Burn
Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions
Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to…
- Trial name
- NCT05170620
- Testing
- laser ablation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Tongji Hospital
Anal Cancer, Squamous Intraepithelial Lesions
Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
This study aims to learn more about anal cancer risk in men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) to prevent HIV.
- Conditions
- Anal Cancer, Squamous Intraepithelial Lesions, HSIL, High Grade Squamous Intraepithelial Lesions, LSIL, Low-Grade Squamous Intraepithelial Lesions
- Trial name
- SCOPE (NCT07029152)
- Testing
- Anal smear, Self-administered questionnaire, EQ-5D-5L questionnaire
- Where
- 8 sites in Belgium
- Volunteers
- 296 people
- Sponsor
- Universitair Ziekenhuis Brussel
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population
- Conditions
- HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma, Anal HSIL
- Trial name
- NCT06949800
- Testing
- EXE-346 Probiotic, Usual Care High Resolution Anoscopy (HRA)
- Where
- 2 sites in United States, Puerto Rico
- Volunteers
- 90 people
- Sponsor
- University of California, San Francisco
High Grade Squamous Intra-epithelial Lesion (HSIL)
Study of Pomalidomide in Anal Cancer Precursors
This is a single centre open label phase II trial to determine the antitumor efficacy of the oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated high grade squamous intra-epithelial…
- Trial name
- SPACE (NCT03113942)
- Testing
- Pomalidomide 2 MG Oral Capsule [Pomalyst]
- Where
- Australia
- Volunteers
- 26 people
- Sponsor
- Kirby Institute
Human Papilloma Virus, Human Immunodeficiency Virus
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
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.
- Conditions
- Human Papilloma Virus, Human Immunodeficiency Virus, Anal Intraepithelial Neoplasia, High-Grade Squamous Intraepithelial Lesions
- Trial name
- NCT06233331
- Testing
- Dose Level 1 ACU-D1 ointment, Dose Level 2 ACU-D1 ointment, Dose Level 3 ACU-D1 ointment
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Emory University
Anal Intraepithelial Neoplasia (AIN), High-grade Squamous Intraepithelial Lesions (HSIL)
A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).
- Trial name
- NCT02189161
- Testing
- Radiofrequency Ablation (Barrx™)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
HIV, AIDS
HIV Indicator Diseases Survey Across Europe - UK Arm
In Europe many patients infected with HIV remain undiagnosed, although this percentage varies between 15-80% across the continent. In the UK it is estimated to be 27%.
- Conditions
- HIV, AIDS, Indicator Diseases/Indicator Conditions
- Trial name
- NCT01196468
- Testing
- HIV test (serological or salivary), Interview
- Where
- 2 sites in United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
Anal Carcinoma, HIV Infection
Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men
This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM).
- Conditions
- Anal Carcinoma, HIV Infection, Human Papillomavirus Infection
- Trial name
- NCT02816879
- Testing
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- Jonsson Comprehensive Cancer Center
Anal Intraepithelial Neoplasia 2, Anal Intraepithelial Neoplasia 1
Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens
Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors.
- Conditions
- Anal Intraepithelial Neoplasia 2, Anal Intraepithelial Neoplasia 1, Anal Cancer, High-Risk Cancer
- Trial name
- NCT06327568
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- European Institute of Oncology
HPV Infection, Cervical/Anal Dysplasia
HPV in Adolescents
This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.
- Trial name
- NCT01788852
- Where
- 3 sites in Thailand
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Anal Cancer
SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia.
- Trial name
- NCT00052897
- Testing
- HspE7
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Cancer Institute (NCI)
Anal Neoplasm
VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2
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…
- Trial name
- NCT03499795
- Testing
- VGX-3100, CELLECTRA™ 5PSP
- Where
- 3 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Inovio Pharmaceuticals
Human Papilloma Virus, Anal Dysplasia
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
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…
- Conditions
- Human Papilloma Virus, Anal Dysplasia, HIV
- Trial name
- PROTECT (NCT06624839)
- Testing
- Human papillomavirus (HPV) vaccine, 9-valent
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Anal Intraepithelial Neoplasia, Anal Cancer
HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL
Human 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…
- Conditions
- Anal Intraepithelial Neoplasia, Anal Cancer, Human Papilloma Virus
- Trial name
- NCT03947775
- Testing
- 9-valent HPV vaccination
- Where
- 4 sites in Canada
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Human Papillomavirus Infection
A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine
This study is to demonstrate that the administration of the investigational vaccine can reduce the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3)…
- Trial name
- NCT05668572
- Testing
- Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli), Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）
- Where
- 3 sites in China
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- Beijing Health Guard Biotechnology, Inc
Anal Cancer, Neoplasm of Uncertain Malignant Potential
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
RATIONALE: Infrared coagulator ablation may be effective in preventing the development of anal cancer in patients with anal neoplasia PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how…
- Conditions
- Anal Cancer, Neoplasm of Uncertain Malignant Potential, Nonneoplastic Condition, Precancerous Condition
- Trial name
- NCT01164722
- Testing
- clinical observation, infrared photocoagulation therapy
- Where
- 7 sites in United States
- Volunteers
- 120 people
- Sponsor
- AIDS Malignancy Consortium
HIV Testing, Linkage to Care
Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM
Objectives 1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV voluntary counseling and testing (VCT) 2.
- Trial name
- NCT01637324
- Where
- Thailand
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Thai Red Cross AIDS Research Centre