Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Acetic Acid

Retinol acetate

Detection of anal HSIL in a routine colonoscopy by using acetic acid and NBI/BLI.

Detection of anal HSIL in a routine colonoscopy.

Andreia Albuquerque, MD PhD

HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.

Procedures in all patients:

1. Digital anorectal evaluation
2. Colonoscopy with retroflection and visualization of the anal squamocolumnar junction
3. After identification of this area 5% acetic acid will be applied.
4. Visualization under NBI/BLI.
5. Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).

ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)

University Fernando Pessoa

Infections

Symptoms and General Pathology

Digestive System Diseases

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Papilloma

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Anal Cancer

The radiofrequency ablation (RFA) or Barrx™ Ablation System used in this protocol comprises an RFA generator (Barrx™ FLEX) and the Barrx™ Anorectal Wand. The generator and wand are cleared by the FDA for human use and the wand is specifically cleared for treatment of anal neoplasia. The present FDA indication for use statement is: "The Barrx™ catheters are indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus. Indications include esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomata, Barrett's esophagus, Dieulafoy lesions, angiodysplasia, gastric antral vascular ectasia, and radiation proctitis."

BARRX™ Anorectal Wand

Murad M Khan, BA

Stephen E Goldstone, MD

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.

A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand

Histologic clearance of all HSIL within the ETZ on a patient and lesion basis at 12 months from first RFA

Stephen E. Goldstone

Surgeon

Immune System Diseases

Uterine Cervical Neoplasms

Acquired Immunodeficiency Syndrome

HIV Infections

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

Topical ABI-1968

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.

An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions

Number of subjects with complete and or partial regression of cHSIL by Histopathology

Changes from baseline in HPV viral load following multiple doses of ABI-1968 Topical Cream

Number of Adverse Events related to treatment

Plasma concentrations of ABI-1968 over time

Antiva Biosciences

In this study, women with pathologically confirmed HSIL(CIN2, 3) or women with cervical carcinoma in situ or early invasive cancer will be included. All participants will have four follow-up visits at enrollment and at months 6, 12, and 24.

Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.

Follow up

Binhua Dong

Pengming Sun

Caiping Deng

Fang Xie, M.D

Xianqian Chen

Yisheng Lin

Zheng Zheng

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.

A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.

Samples from the cervix and vagina containing relevant cells, tissues and secretions, as well as peripheral blood samples.

Prognostic Study of HPV Virus Integration in Women With HSIL

Prognostic Study of Different HPV Virus Integration in Women With HSIL

All participants were tested for cervical cytology at the time of baseline.

All participants were tested for cervical cytology at 6-month follow-up for all participants.

All participants were tested for cervical cytology at 12-month follow-up

Cervical exfoliated cells and vaginal tissue samples were collected was performed at All participants were tested for cervical cytology at 24-month follow-up

All participants underwent vaginal secretion sequencing at baseline.

All participants underwent vaginal secretion sequencing at 6-month follow-up

All participants underwent vaginal secretion sequencing at 12-month follow-up

All participants underwent vaginal secretion sequencing at 24-month follow-up

Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.

Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants.

Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.

Human Papillomavirus (HPV) viral integration test was performed at 24-month follow-up for all participants.

All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.

All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.	NCT05060640	AIN3 AIN2 HSIL, High Grad...	Detection of an...	-	University Fernando Pessoa
A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand	NCT03302858	HSIL, High Grad... Anal Cancer HPV-Related Squ... Human Papilloma... Human Papilloma... Ain III	BARRX™ Anorecta...	18 Years - 75 Years	Laser Surgery Care
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.	NCT03697226	HSIL of Cervix HSIL, High Grad... High-Grade Cerv... Human Papilloma... HIV Negative Cervical Cancer CIN - Cervical ... Cervical Neopla... Cervical Dyspla...	Topical ABI-196...	25 Years - 50 Years	Antiva Biosciences
Prognostic Study of HPV Virus Integration in Women With HSIL	NCT05745597	HPV Infection Virus Integrati... HSIL, High Grad...	Follow up	-	Fujian Maternity and Child Health Hospital
ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.	NCT05060640	AIN3 AIN2 HSIL, High Grad...	Detection of an...	-	University Fernando Pessoa
ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.	NCT05060640	AIN3 AIN2 HSIL, High Grad...	Detection of an...	-	University Fernando Pessoa
A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand	NCT03302858	HSIL, High Grad... Anal Cancer HPV-Related Squ... Human Papilloma... Human Papilloma... Ain III	BARRX™ Anorecta...	18 Years - 75 Years	Laser Surgery Care

Spots Global Cancer Trial Database for hsil, high grade squamous intraepithelial lesions