Clinical trials: HSIL, High Grade Squamous Intraepithelial Lesions
Anal High Grade Squamous Intraepithelial Lesion
The Effectiveness of High Resolution Microendoscopy for People Living With HIV
The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated…
- Trial name
- NCT04563754
- Testing
- mHRME (Mobile High resolution microendoscope), Proflavine Hemisulfate, High resolution anoscopy
- Where
- 3 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
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
Cervical Intraepithelial Neoplasia
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing reagent called Candin®) in adult females over…
- Trial name
- NCT02481414
- Testing
- PepCan, Candin®
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- University of Arkansas
Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP)…
- Conditions
- Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL
- Trial name
- REVEAL 1 (NCT03185013)
- Testing
- VGX-3100, Electroporation (EP)
- Where
- 60 sites in United States, Argentina and 17 more
- Volunteers
- 201 people
- Sponsor
- Inovio Pharmaceuticals
Cervical High Grade Squamous Intraepithelial Lesion
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL
Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor response to treatment of cervical cancer precursors.
- Trial name
- NCT01928225
- Testing
- Human Papillomavirus vaccine
- Volunteers
- 180 people
- Sponsor
- University of Witwatersrand, South Africa
Precancerous Condition
Activating Collaborative CIS Support Via Targeted Provider Mailing
RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer Information Service may be more effective than a standard reminder letter in helping patients who have had an abnormal Pap test keep their…
- Trial name
- NCT00873288
- Testing
- Usual care mailing intervention, CIS support mailing intervention
- Where
- 2 sites in United States
- Volunteers
- 254 people
- Sponsor
- Northwestern University
HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
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…
- Trial name
- AIN (NCT01970787)
- Testing
- Radiofrequency Ablation (RFA) using the HALO Ablation System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Medtronic - MITG
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
High Grade Anal Canal Squamous Intraepithelial Neoplasia, Human Immunodeficiency Virus
Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions
This trial develops a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions.
- Trial name
- NCT04276935
- Testing
- Interview, Quality-of-Life Assessment, Questionnaire Administration
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- AIDS Malignancy Consortium
Cervical Squamous Cell Carcinoma In Situ, Vulvar High Grade Squamous Intraepithelial Lesion
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3.
- Trial name
- NCT03267680
- Testing
- Cyclophosphamide, Indomethacin, IRX-2
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- University of Southern California
Papillomavirus Infections, Cervical Intraepithelial Neoplasia
E7 TCR T Cells for Human Papillomavirus-Associated Cancers
Background: Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have an HPV protein called E7 inside of their cells.
- Conditions
- Papillomavirus Infections, Cervical Intraepithelial Neoplasia, Carcinoma In Situ, Vulvar Neoplasms
- Trial name
- NCT02858310
- Testing
- E7 TCR cells, Aldesleukin, Fludarabine
- Where
- 2 sites in United States
- Volunteers
- 224 people
- Sponsor
- National Cancer Institute (NCI)
AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia
HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV
This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV.
- Conditions
- AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia, HIV Infection
- Trial name
- COVENANT (NCT03284866)
- Testing
- Laboratory Biomarker Analysis, Recombinant Human Papillomavirus Nonavalent Vaccine, Saline
- Where
- 6 sites in Kenya, Malawi and 3 more
- Volunteers
- 535 people
- Sponsor
- AIDS Malignancy Consortium
Cervical Intraepithelial Neoplasia, Uterine Cervical Dysplasia
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth).
- Trial name
- NCT00285207
- Testing
- A007
- Where
- 29 sites in United States
- Volunteers
- 147 people
- Sponsor
- Tigris Pharmaceuticals
Anus Neoplasms
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
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).
- Trial name
- AIJP (NCT00622440)
- Testing
- AIJP (Arnebia Indigo Jade Pearl)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of California, San Francisco
Anal Intraepithelial Neoplasia, High-grade Squamous Intraepithelial Lesion
Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions
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…
- Conditions
- Anal Intraepithelial Neoplasia, High-grade Squamous Intraepithelial Lesion, HIV Infection
- Trial name
- NCT02059499
- Testing
- imiquimod, fluorouracil, questionnaire administration
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 91 people
- Sponsor
- AIDS Malignancy Consortium
Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
HPV-303 is a prospective, randomized, double-blind, placebo-controlled study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed…
- Conditions
- Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL
- Trial name
- NCT03721978
- Testing
- VGX-3100, CELLECTRA™-5PSP
- Where
- 53 sites in United States, Argentina and 8 more
- Volunteers
- 203 people
- Sponsor
- Inovio Pharmaceuticals
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
Human Papillomavirus, HPV-16
Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
Background: Vulvar high-grade squamous intraepithelial lesion (HSIL) is caused by infection of the vulva with human papillomavirus (HPV). In a small percentage of cases, vulvar HSIL can turn into cancer.
- Conditions
- Human Papillomavirus, HPV-16, High Grade Squamous Intraepithelial Lesion
- Trial name
- NCT03197025
- Testing
- Aldesleukin, E6 T Cell Receptor (TCR)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Anal Cancer, High-grade Squamous Intraepithelial Lesion
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
The randomized phase of the trial compared topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL).
- Conditions
- Anal Cancer, High-grade Squamous Intraepithelial Lesion, HIV Infection, Human Papilloma Virus Infection
- Trial name
- ANCHOR (NCT02135419)
- Testing
- imiquimod, fluorouracil, infrared photocoagulation therapy
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 4,446 people
- Sponsor
- AIDS Malignancy Consortium
Anal Cancer, Precancerous Condition
Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses and may stop these lesions from becoming…
- Trial name
- NCT00550589
- Testing
- cidofovir, DNA methylation analysis, gene expression analysis
- Where
- 8 sites in United States
- Volunteers
- 33 people
- Sponsor
- AIDS Malignancy Consortium