Clinical trials: HSIL, High-Grade Squamous Intraepithelial Lesions, open to volunteers
High-grade Squamous Intraepithelial Lesion (HSIL)
Evaluation of NWRD09 for HPV-16 Related Cervical HSIL
This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD09 administered by intramuscular (IM) injection in adult women with histologically confirmed cervical high grade…
- Trial name
- NCT07712692
- Testing
- NWRD09 Injection
- Where
- 15 sites in China
- Volunteers
- 156 people
- Sponsor
- Newish Biotech (Wuxi) Co., Ltd.
Cervical Intraepithelial Neoplasia, Squamous Intraepithelial Lesions of the Cervix
Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (<30 years), but evidence is insufficient on whether it is also advisable for older women.
- Conditions
- Cervical Intraepithelial Neoplasia, Squamous Intraepithelial Lesions of the Cervix, Uterine Cervical Dysplasia
- Trial name
- NCT04783805
- Testing
- Conservative management with regular follow-up, Conization
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
High-grade Squamous Intraepithelial Lesions (HSIL), Cervical Conization
Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation
The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after…
- Trial name
- NCT06713655
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University
High-grade Squamous Intraepithelial Lesion (HSIL)
Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL
This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) in adult women with histologically…
- Trial name
- NCT07175662
- Testing
- NWRD08 administered by electroporation
- Where
- 5 sites in China
- Volunteers
- 150 people
- Sponsor
- Newish Biotech (Wuxi) Co., Ltd.
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
High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection
Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)
The goal of this study is to learn about the safety, tolerability, immunogenicity and preliminary efficacy of BBM-C101 injection in patients with High-Grade Squamous Intraepithelial Lesion of the cervix.
- Trial name
- NCT07668960
- Testing
- BBM-C101
- Where
- 4 sites in China
- Volunteers
- 60 people
- Sponsor
- Shanghai Mianyi Biopharmaceutical Co., Ltd.
I) Atypical Squamous Cells of Undetermined Significance (ASC-US), II) Atypical Glandular Cells of Uncertain Significance (AGUS)
Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer
This study compares how effective is the molecular screening (a blood test) using Pap smear as reference, that is, a comparison of these tests abilities to detect precursor lesions and cervical cancer among women of an open…
- Conditions
- I) Atypical Squamous Cells of Undetermined Significance (ASC-US), II) Atypical Glandular Cells of Uncertain Significance (AGUS), III) Cervical Intraepithelial Neoplasia (CIN), CIN-1, CIN-2, CIN-3, IV) Low-grade Squamous Intraepithelial Lesion (LSIL)
- Trial name
- NCT07480902
- Testing
- Physical examination, Liquid-based cytology, Molecular screening
- Where
- Mexico
- Volunteers
- 558 people, healthy volunteers welcome
- Sponsor
- Timser SAPI de CV
Cervical Intraepithelial Neoplasia, Papillomavirus Infections
Hexaminolevulinate Photodynamic Therapy (HAL-PDT) With Deferred Surgery Versus Surgery for High-grade Squamous Intraepithelial Lesions (HSIL)
High-grade squamous intraepithelial lesions (HSIL), encompassing cervical intraepithelial neoplasia grade 2 (CIN2) with p16 positivity and grade 3 (CIN3), are precancerous conditions that require effective intervention.
- Trial name
- Aurora (NCT07669363)
- Testing
- Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC), HAL 5% with illumination
- Where
- 28 sites in China
- Volunteers
- 230 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Vulvar Diseases, HPV Infection
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
- Conditions
- Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia
- Trial name
- ART-VIN IIB (NCT06075264)
- Testing
- Artesunate ointment
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Frantz Viral Therapeutics, LLC
HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.
- Conditions
- HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2, HPV (Human Papillomavirus)-Associated, Photodynamic Therapy (PDT)
- Trial name
- PDT for CIN2 (NCT07306260)
- Testing
- ALA-PDT, LEEP surgery
- Where
- 5 sites in China
- Volunteers
- 560 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Cervical High Grade Squamous Intraepithelial Lesion, Cervical Intraepithelial Neoplasia Grade 2/3
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
Imiquimod is a good non-invasive treatment option for women with cervical high-grade squamous intraepithelial neoplasia (cHSIL), especially those with a possible (future) pregnancy wish.
- Conditions
- Cervical High Grade Squamous Intraepithelial Lesion, Cervical Intraepithelial Neoplasia Grade 2/3, CIN 2/3, Cervical Intraepithelial Neoplasia
- Trial name
- PRedICT-TOPIC (NCT05405270)
- Testing
- Imiquimod, 3x vaginal swab for microbiome analysis, Expectative management
- Where
- 15 sites in Netherlands
- Volunteers
- 410 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
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
HSIL, High-Grade Squamous Intraepithelial Lesions, Vaginal Microbiome
Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod.
- Conditions
- HSIL, High-Grade Squamous Intraepithelial Lesions, Vaginal Microbiome, Biomarkers
- Trial name
- NCT06356012
- Testing
- Imiquimod, Loop Electrosurgical Excision Procedure
- Where
- Brazil
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Barretos Cancer Hospital
Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site
Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions
Randomized, placebo-controlled phase 3 trial to evaluate nonavalent HPV vaccine as a secondary prevention in patients treated for human papilloma virus related high-grade squamous intraepithelial lesions.
- Conditions
- Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Penile Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Cervical Site
- Trial name
- BioHPV (NCT07431502)
- Testing
- HPV vaccine
- Volunteers
- 984 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
High-grade Squamous Intraepithelial Lesion (HSIL)
NWRD09 for HPV-16 Related Cervical HSIL
This is a single-arm, open label, multi-center clinical study to evaluate the safety, tolerability and immunogenicity HPV16 targeted mRNA therapeutic vaccine (NWRD09) in HPV16 related cervical high-grade squamous intraepithelial…
- Trial name
- NCT07047989
- Testing
- NWRD09 injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Newish Biotech (Wuxi) Co., Ltd.
Cervical Cancer, High Grade Sil
Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.
Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still undiagnosed and about 50% of diagnosed cases succumb per year.
- Conditions
- Cervical Cancer, High Grade Sil, CIN2
- Trial name
- DiaVACCS (NCT02956031)
- Testing
- Screening, Colposcopy, LLETZ
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- University of Pretoria
Anal High-grade Squamous Intraepithelial Lesion, Anal HSIL
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment 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 HSIL, Anal HPV Infection, AIN
- Trial name
- ART-AIN IIB-2 (NCT06206564)
- Testing
- Artesunate ointment
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- Frantz Viral Therapeutics, LLC