Clinical trials: Anal Intraepithelial Neoplasia, active
HPV Infection, Dysplasia Anus
Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.
- Conditions
- HPV Infection, Dysplasia Anus, Oral Cavity Disease
- Trial name
- PAPIMALE (NCT05911750)
- Testing
- Anal pap smear and oral swab for cytology and HPV testing
- Where
- Spain
- Volunteers
- 384 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
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
Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL
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)
- Conditions
- Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition, AIN 2/3, HPV Infection
- Trial name
- anal HSIL HIV- (NCT05555862)
- Testing
- Artesunate
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Frantz Viral Therapeutics, LLC
High-Grade Anal Intraepithelial Neoplasia
Lopinavir/Ritonavir in PLWH With High-Grade AIN
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…
- Trial name
- NCT05334004
- Testing
- Lopinavir / Ritonavir
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Wisconsin, Madison
HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias
Screening Women With Prior HPV for Anal Neoplasia
The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.
- Conditions
- HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias, Early Stage Lower Genital Tract Cancers
- Trial name
- SWAN (NCT05217940)
- Testing
- Diagnostic tests for anal cancer screening
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia
A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males
This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen…
- Conditions
- Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Penile/Perianal/Perineal Cancer, Anal Cancer
- Trial name
- NCT06866574
- Testing
- Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli), Aluminum Adjuvant
- Where
- 4 sites in China
- Volunteers
- 9,300 people, healthy volunteers welcome
- Sponsor
- Xiamen University
Human Papillomavirus Infection, Anal HPV Infection
Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression
Anal canal cancer is primarily associated with persistent infection by high-risk human papillomavirus (HR-HPV), particularly HPV-16.
- Conditions
- Human Papillomavirus Infection, Anal HPV Infection, Human Papillomavirus 16 Infection
- Trial name
- EPAHTOS (NCT07858201)
- Testing
- Anal Self-Sampling for High-Risk HPV Detection
- Volunteers
- 190 people
- Sponsor
- University Hospital, Montpellier
Vulvar Cancer, Cervical Cancer
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal…
- Conditions
- Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia
- Trial name
- Vulvar-AIN (NCT03061435)
- Testing
- Screening anal Pap smear - No high-resolution anoscopy, Screening anal Pap smear - High-resolution anoscopy
- Where
- Canada
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Dr. Danielle Vicus
Anal High Grade Squamous Intraepithelial Lesion
Safety of Anal Curcumin
The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions (aHSIL) (high-grade anal precancerous cells or high-grade abnormal cells) in people living with HIV to avoid current…
- Trial name
- NCT06626230
- Testing
- Curcuminoid Capsules
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Lisa Flowers
Papillomavirus Vaccines, Human Immunodeficiency Virus
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
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.
- Conditions
- Papillomavirus Vaccines, Human Immunodeficiency Virus, Papillomavirus Infection, Serology
- Trial name
- AGO-Gard (NCT05266898)
- Testing
- Human papillomavirus 9-valent vaccine, recombinant, human papillomavirus vaccine, recombinant
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections
A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)
This is a non-randomized, open label study to assess the reduction of Human Papillomavirus (HPV) infectivity and transmission in women positive for HPV16 and/or 18 in a cervical, oral and anal sample and vaccinated with…
- Conditions
- Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections, High-risk HPV, HPV-16/ 18
- Trial name
- RIFT-HPV (NCT05334706)
- Testing
- Nonavalent HPV vaccine (9vHPV/Gardasil-9™).
- Where
- Spain
- Volunteers
- 69 people
- Sponsor
- Miquel Angel Pavon Ribas
HPV-Related Carcinoma, HPV Infection
Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.
The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD survivors and additionally to establish an exact risk for each of HPV-related gynecological precancers/cancers.
- Trial name
- NCT06574087
- Testing
- hrHPV test and cytology
- Where
- Poland
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- PCK Marine Hospital in Gdynia
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 Squamous Intraepithelial Neoplasia
Seville Cohort of People Living With HIV at Risk for Anal Cancer
There is increasing awareness of augmenting risk of anal cancer in people living with HIV, especially among men who have sex with men (MSM).
- Trial name
- SeVIHanal (NCT03713229)
- Testing
- Screening for anal squamous intraepithelial lesions
- Where
- Spain
- Volunteers
- 3,000 people
- Sponsor
- Hospitales Universitarios Virgen del Rocío
AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma
Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico
This clinical trial aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV).
- Conditions
- AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma, High Grade Anal Intraepithelial Neoplasia, High Grade Cervical Intraepithelial Neoplasia
- Trial name
- CAMPO-101 (NCT05074264)
- Testing
- Biopsy, Biospecimen Collection - Anal, Biospecimen Collection - Cervical
- Where
- 4 sites in Mexico, Puerto Rico
- Volunteers
- 1,586 people
- Sponsor
- University of California, San Francisco
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 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
Education, Medical
Implementation of Anal Cancer Screening and Treatment in Nigeria
The study is a feasibility pilot trial testing 2 types of training protocols on a single physician. The first training protocol is the current standard and was developed in high-income settings.
- Trial name
- IMPACT (NCT05817370)
- Testing
- Enhanced Training on screening and treatment of HSIL (e-STH)
- Where
- Nigeria
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
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