Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Dysplasia

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Acceptability of Liger Medical Thermocoagulator treatment

Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)

Liger Medical Thermocoagulator

Silvia de Sanjose, MD, PhD

This was a prospective study to evaluate the short-term safety and acceptability of the Liger Medical thermal coagulation device for treatment of cervical precancerous lesions. Study results will inform the Honduras Ministry of Health regarding potential use of the Liger device for precancer treatment in Honduras and results may be of interest to other Latin American settings as well.

The research was conducted in the Tegucigalpa Region in Honduras in 4 health facilities in urban and peri-urban settings. Participants were women ages 30-49 who met the study eligibility criteria. Human papilloma virus (HPV) and visual inspection with acetic acid (VIA)-positive women who were eligible for ablative treatment were offered thermal coagulation with the Liger instrument to treat their lesions and asked about acceptability of the treatment. At this visit, biopsies were also be taken. Women were followed-up at 1 month to evaluate short-term safety outcomes with a physical exam and receive their biopsy results. Depending on their biopsy results, they will be asked to return for repeat screening, referred for further treatment or asked to come back for a 12-month study visit. At the 12-month visit after treatment, women were followed up to evaluate cure rates.

A second investigational device, Pocket Colposcope, was used to take cervix photos at the enrollment and 12-month study visit with participant consent. The photos were used to explore factors influencing treatment failure. De-identified photos and women's diagnosis information were also shared with the device developers, Duke University, for the purposes of improving their device. Women had the option to opt out of having cervix photos taken and still participate in the treatment portion of the study.

Honduras Liger Thermocoagulator Study

Evaluation of the Liger Medical Thermocoagulator for Treatment of Cervical Intraepithelial Lesions in Honduras

Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced.

Level of pain women experienced during the thermal coagulation procedure will be calculated by the number and percent of women indicating minimal to worst possible levels of pain using the Wong-Baker FACES® pain rating scale. Women's acceptability will also be assessed by asking if they would recommend the Liger Thermocoagulator treatment to a friend or relative who needed similar treatment as well as reasons for her response.

Wong-Baker FACES® pain rating scale:

MINIMUM value: 0 (no hurt = best outcome) Value: 2 (hurts little bit) Value: 4 (hurts little more) Value: 6 (hurts even more) Value: 8 (hurts lot more) MAXIMUM value: 10 (hurts whole lot = worst outcome)

Percentage of participants with no evidence of cervical intraepithelial neoplasia grade 2 or grade 3 (CIN2-3) at 12 months, based on histological evaluation following the standard criteria from WHO Classification of Tumours, 5th Edition, Volume 4: Female Genital Tumours.

Qualitative analysis of cervical photos by an expert colposcopist to explore factors associated with treatment failure, compared characteristics of the cervix and precancerous lesions among women with CIN2-3 at Visit 1 (enrollment) in women whose treatment resulted in lesion disappearance (\<CIN2), and women with persistent lesions (CIN2-3) at 12 months. Adequacy of the image included focus, blur, and capture; a well focused image without obstructions (blood, cysts) that captured the whole ectocervix and cervical os was considered adequate. For squamous columnar junction and transformation zone (TZ) visibility, TZ1 signifies a fully visible TZ, TZ2 signifies the TZ or visible lesions extend into the cervical canal and the TZ covers more than 75% of the ectocervix, and TZ3 signifies that the TZ is not at all visible, in accordance with WHO recommendations. Baseline histology reports histological evaluation of lesions as cervical intraepithelial neoplasia grade 2 (CIN2) or 3 (CIN3).

Ashonplafa

Ministry of Health, Honduras

PATH

Received thermal coagulation treatment for cervical precancer.

Thermocoagulation Treatment

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Honduras

Region of Enrollment

No differences from the assignment in the Participant Flow section.

Dr. Silvia de Sanjose

Colorless watery discharge

Brown/black discharge

Foul-smelling, pus-colored discharge

Bleeding

Pain while urinating

Severe lower abdominal pain

Fever

All participants were included. Note: Participants could report more than one discomfort or problem experienced.

Short-term Safety Concerns for Ablative Treatment

FACES® level of pain: 0 - no hurt

FACES® level of pain: 2 - hurts little bit

FACES® level of pain: 4 - hurts little more

FACES® level of pain: 6 - hurts even more

FACES® level of pain: 8 - hurts whole lot

FACES® level of pain: 10 - hurts worst

Would recommend treatment to friend/relative

Would not recommend treatment to friend/relative

Not applicable; all participants were included.

Acceptability of Treatment by Women

CIN2-3 at Baseline

< CIN2 at Baseline

Percentage of Participants With no Evidence of CIN2-3 Lesions 12 Months After Thermal Coagulation

Baseline photo: Adequate

Baseline photo: Inadequate

Squamous columnar junction visibility: TZ1

Squamous columnar junction visibility: TZ2

Squamous columnar junction visibility: TZ3

Squamous columnar junction visibility: Missing

Visible abnormal areas: 0

Visible abnormal areas: 1

Visible abnormal areas: 2+

Visible abnormal areas: Not evaluable

Visible abnormal areas: Missing

Location of the lesion: Inside the TZ

Location of the lesion: Outside the TZ

Location of the lesion: Not evaluable

Mosaic of the worst lesion: Fine

Mosaic of the worst lesion: Coarse

Mosaic of the worst lesion: No mosaic

Mosaic of the worst lesion: Not evaluable

Border of the worst lesion: Irregular

Border of the worst lesion: Sharp

Border of the worst lesion: Not evaluable

Possible diagnosis: No lesion

Possible diagnosis: LSIL

Possible diagnosis: HSIL

Possible diagnosis: Invasion

Possible diagnosis: Not evaluable

Baseline histology: CIN2

Baseline histology: CIN3

Size of worst lesion (% coverage): 0-4

Size of worst lesion (% coverage): 5-50

Size of worst lesion (% coverage): >50

Women with CIN2-3 at baseline and CIN2-3 at 12 months

Evidence of Treatment Failure

Women with CIN2-3 at baseline and \<CIN2 at 12 months

No Evidence of Treatment Failure

Treatment Failure

Overall Study

Infections

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Arm A: scheme A (21 days / 1 cannula per day + 7 days rest) x 1 month + alternate days up to 6 months (except for menstruation days)

Arm B: scheme B (21 days / 1 cannula per day + 7 days rest) x 3 months + alternate days up to 6 months (except menstruation days)

Arm C: usual clinical practice: no treatment

Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution

Papilocare vaginal gel

Javier Cortés Bordoy, MD

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1).

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (usual clinical practice -without treatment-). Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. Patients will visit the site into a total of 5 visits throughout the study.

Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV

Ensayo clínico, Aleatorizado, Abierto, de Grupos Paralelos y Con Grupo Control, Para Explorar la Eficacia Del Gel PAPILOCARE en la reparación de la Mucosa cérvico-vaginal Con Lesiones Causadas Por VPH (Ensayo Clínico PALOMA)

It must be discussed with investigators team

Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image, 6 months after the start of treatment.

Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image at 3 and 12 months after the start of treatment.

Evaluate the reeptielization of the cervico-vaginal mucosa months after the start of treatment measured by likert scale, using a total of 5 points (1 is severe ectopy + external bleeding, 2 is severe or extensive ectopy:\> 50%, 3 is moderate ectopy: 25-50%, 4 is mild ectopy: \<25% and 5 is no ectopy).

Evaluate vaginal health status from the start of treatment measured by Bachmann Index, it contains 5 domains that evaluate elasticity, type of secretion, pH, epithelial integrity and moisture, scoring each of them from 1 to 5, considering the maximum score as the best vaginal health status.

Evaluate the satisfaction of papilocare gel use by the patients after the start of treatment measured by likert scale, it is a single-item instrument that assesses the degree of satisfaction experienced by the patient with a graded response of 7 values ranging from 1 (satisfied) to 7 (not satisfied at all).

Evaluate the therapeutic compliance from the start of treatment

Adknoma Health Research

Procare Health Iberia S.L.

Recurrence

Vaginal Diseases

Patients with HPV-related disease including cervical and vaginal lesions

Patients will have laser surgery for managing HPV-related lesions

LASER surgery

Giorgio Bogani

In the recent years, the widespread adoption of primary and secondary preventions has dramatically reduced the incidence of cervical cancer in developed countries. However, cervical cancer still represents a major health concern, being the third most common malignancy among women aged \<39 years, and the second most common cause of death for cancer among females between 20 and 39 years in the United States.

Cervical cancer is one of the most preventable types of cancer, since it develops over a long time and the causative agent has been recognized. Persistent infection from human papillomavirus (HPV) is the main factor causing cervical cancer. Generally, persistent HPV infection causes cervical dysplasia (also known as cervical intraepithelial neoplasia), which potentially evolves in cancer. Although the majority of women with HPV infection will never develop lesions, a relatively high number of women is at risk of developing cervical dysplasia. Women with cervical dysplasia who have appropriate follow-up and treatments are at low risk of developing cervical cancer. However, recurrent cervical dysplasia is a well-known risk factor for cervical cancer. Additionally, recurrent cervical dysplasia might be cause of morbidity since adjunctive surgical treatments are associated with fertility and obstetrical issues in women who wish to preserve their childbearing potential. With this background, identifying the best treatment modality for patients with cervical dysplasia is of paramount importance.

However, the management of residual/recurrent dysplasia after primary treatment is often challenging. Moreover, it is important to classify patients based on their risk of having persistent/recurrent dysplasia after primary treatment. Assessing these classes of risks is useful in tailoring appropriate surveillance and determining the need for adjunctive treatments. Our study group estimated the risk of developing persistent/recurrent dysplasia in several investigations, observing that positive surgical margins, surgical techniques, high-risk HPV infection at the time of diagnosis, and HPV persistence are the main prognostic factors. Our data corroborated a considerable body of literature investigating this issue. However, it is difficult to estimate the risk of developing persistent/recurrent dysplasia for each patient.

Similarly, few investigations evaluated outcomes of patientsaffected by vaginal intraepithelial neoplasia with discor-dant results. In fact, there is no consensus on the optimaltreatment modality for those patients. Treatments in-cluded: topical application of imiquimod or 5-fluorouracil(5-FU), as well as ablative and excisional proceduresexecuted via conventional surgery, electrosurgery andcarbon dioxide LASER. The risk of developinginvasive vaginal cancer in those patients remains unclear,ranging between 2% and 12% in different series.Recently, a multi-institutional Italian study reports thatmore than 10% of women initially diagnosed with high-grade vaginal intraepithelial neoplasia are detected withoccult invasive vaginal cancer at the time of excisionalprocedure, thus suggesting the need to achieve a histologi-cal diagnosis before proceeding to ablative or medicaltreatments Here, we aim to evaluate the importance of various prognostic factors in influencing the risk of persistent/recurrent lesions of the uterine cervix and the vagina

Treatments of HPV-related Lesions

Predictors of Recurrence After Treatment of HPV-related Disease

time between surgery and first recurrence

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

All Drugs and Chemicals

Micronutrients

Hematinics

Antineoplastic Agents

Neuroprotective Agents

Vitamins

Flavonoid

Hyaluronic Acid

Folic Acid

Epigallocatechin gallate

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Trace Elements

Adjuvants, Immunologic

Immunologic Factors

Viscosupplements

Protective Agents

Antioxidants

Folinic Acid

Methylcobalamin

Epigallocatechin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks.

One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid.

Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid

Cesare Aragona, MD

To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.

40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.

Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.

Lo.Li.Pharma s.r.l

Rare Diseases

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Negative high risk (HR)-HPV, cytology co-test

It is a highly sensitive and specific droplet digital PCR assay for absolute quantification of circulating tumor HPV DNA for the most prevalent HPV types that will determine if a woman has cHPVDNA

digital PCR (dPCR) assay

Tuvara J King

Tuvara K King

Shivani Sud, MD

The purpose of this study is to see if circulating HPV DNA (cHPVDNA) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (CIN) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan.

cHPVDNA is detectable in plasma of patients with invasive disease and CIN 1-3, and with the development of a highly sensitive and specific droplet digital Polymerase Chain Reaction (PCR) assay, it is hoped to be identified more prevalently and thus can improve risk stratification and help produce personalized treatment decisions and may be more cost-efficient. Plasma samples and cervical swabs will be collected from patients in University of North Carolina (UNC) Gynecology clinics, and some patients will also provide a urine sample. Those receiving biopsies or colposcopies and will come back to clinic 2-4 weeks post-excision for collection of another blood specimen. Using plasma samples and pathology results, we will characterize the relationship between plasma cHPVDNA levels and 1) CIN 1 versus CIN 2-3 pathology 2) CIN 2-3 pre-excision and 2-4 weeks post-excision. We will accrue three cohorts of 25, 30, 30 patients corresponding to 1) Control 2) CIN 1 3) CIN 2-3. The control cohort will establish background signal in the assay. We will compare the proportion of detectable cHPVDNA levels between CIN 1 and CIN 2-3 cohorts using Fisher's exact test with 80% power, significance level of 10%. Paired t-test will be used to compare pre- and post-excision cHPVDNA levels.

Blood and tissue collected will be retained for 15 years and will be tested for cHPVDNA.

Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia

Application of Plasma Circulating Human Papillomavirus (HPV) DNA Testing to Management of Cervical Intraepithelial Neoplasia

We will quantify cHPVDNA levels in blood plasma from patients with normal screening, CIN 1, and CIN 2-3 cervical disease prior to treatment.

For patients who undergo excisional therapy, we will collect bio-specimens and quantify cHPVDNA levels in plasma during their post-procedure visit.

UNC Lineberger Comprehensive Cancer Center

Persistent Infection

Vaccines

* Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
* Women who sign informed consent.
* Patients with negative results in the first post-surgery control.
* Patients who have received HPV vaccination and provide vaccination card.

* Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
* Women who sign informed consent.
* Patients with negative results in the first post-surgery control.
* Patients who have NOT received HPV vaccination and provide vaccination card.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Honduras Liger Thermocoagulator Study	NCT03510273	Cervix Cancer Cervix Lesion	Liger Medical T...	30 Years - 49 Years	PATH
Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV	NCT04002154	Human Papilloma... Human Papilloma... Cervix Lesion	Papilocare vagi...	30 Years - 65 Years	Procare Health Iberia S.L.
Treatments of HPV-related Lesions	NCT05938192	HPV Cervical Cancer Cervix Lesion Vagina Disease	LASER surgery	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions	NCT05625308	Papilloma Cervix Lesion	Epigallocatechi...	18 Years - 55 Years	Lo.Li.Pharma s.r.l
Treatments of HPV-related Lesions	NCT05938192	HPV Cervical Cancer Cervix Lesion Vagina Disease	LASER surgery	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia	NCT04274465	Cervix Lesion Cervical Cancer	digital PCR (dP...	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.	NCT04171505	Cervix, Dysplas... HPV Infection HPV Vaccine Cervix Lesion	HPV vaccine	18 Years - 100 Years	Hospital San Carlos, Madrid
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.	NCT04199078	Human Papilloma... Human Papilloma... Cervix Lesion	Papilocare vagi...	30 Years - 65 Years	Procare Health Iberia S.L.

Spots Global Cancer Trial Database for cervix lesion