Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

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

Women 21 years of age or older with an LSIL diagnosis

Michael W Kilpatrick, Ph.D.

The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.

oncoFISH Cervical Test for Detection of 3q26 Region Gain

The oncoFISH Cervical Test for Detection of 3q26 Region Gain

Ikonisys, Inc.

Rare Diseases

Squamous Intraepithelial Lesions of the Cervix

Uterine Cervical Dysplasia

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Micronutrients

All Drugs and Chemicals

Hematinics

Other Dietary Supplements

Vitamins

Thioctic Acid

Antioxidants

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Alpha-lipoic Acid

Folate

Vitamin B9

600 mg (2x300 mg) of DL-alpha lipoic acid in capsules, per os daily for 3 months

600 mg (2\*300 mg) of placebo (rice starch) in capsules, per os, daily for 3 months

Treatment group recieves 600 mg of DL-alpha lipoic acid daily, per os, for 3 months.

DL-alpha lipoic acid

Placebo group recieves 600 mg (2x300 mg) of placebo (rice starch) daily, per os, for 3 months

placebo (rice starch)

Dubravka Vitali Čepo, prof

Zinaida Karasalihović, prof

Low-grade squamous intraepithelial lesions (LSIL) are premalignant changes on the cervix that can lead to malignant changes, i. e. cervical cancer. Alpha-lipoic acid is a fatty acid that is naturally found in food, and due to its proven antioxidant and anti-inflammatory effects, it is increasingly used as a dietary supplement, most often to alleviate the symptoms of various neuropathic conditions.

The purpose of this study was to demonstrate efficiency, safety, and clinical benefit of alpha lipoic acid (ALA) in inducing regression of LSIL. The hypothesis is based on the proven role of oxidative stress and inflammation in formation of LSIL and anti-inflammatory and antioxidative efficiency of ALA.

The study was designed as randomized, double-blind, two-arm, placebo-control trial recruiting 100 female patients with diagnosed LSIL. Patients received 600 mg/day of ALA or placebo for 3 months. Progression/regression of LSIL has been defined as primary outcome of the study; inflammation markers and oxidative stress parameters have been defined as secondary outcomes of the study.

Cervical intraepithelial neoplasia (CIN) is premalignant change on the cervix that can lead to malignant changes, i.e., cervical cancer. Today, this term has been replaced by the more recent term squamous intraepithelial lesion (SIL). With the introduction of the term SIL into use (as proposed by Bethesda system), two grades are used to classify premalignant changes of the cervix: SIL of low grade (LSIL) which includes condylomas and mild dysplasia (CIN I), and high-grade squamous intraepithelial lesion (HSIL) that includes changes in terms of medium and high-grade dysplasia (CIN II and CIN III). The main etiological factor that leads to the formation of cervical neoplasia is the human papilloma virus (HPV). Other etiological factors such as smoking, oral therapy contraceptives, sexual habits, chemicals, immunosuppressive therapy, immunodeficiency diseases, socioeconomic living conditions and nutritional status of patients also play a role in the progression of the disease. In addition to the above, inflammation and oxidative stress are also important etiological factors in the development of SIL. Namely, malignant changes on the cervix do not appear on a completely healthy cervix but are always associated with chronic cervicitis.

Alpha-lipoic acid (ALA) is a non-essential fatty acid with numerous metabolic roles and its therapeutic potential is being investigated in many pathophysiological conditions. In addition to acting as a cofactor of numerous signalling pathways in the cell, ALA also has a standard redox potential of -0.32 V, which gives it the ability to regenerate the most important physiological antioxidants in vivo (e.g. vitamin C and E) and makes it one of the most potent natural antioxidants. Given that it is implicated as a modulator of various inflammatory signalling pathways, its anti-inflammatory properties have been investigated by a large number of clinical studies. T This impressive array of cellular and molecular functions has led to significant interest in the research and use of ALA as a dietary supplement. ALA has been proven to improve insulin resistance, relieve symptoms of diabetic neuropathy, combine with phototherapy in the treatment of vitiligo, improve wound healing and increase the effectiveness of reduction diets. Its use as a dietary supplement is currently being investigated in dementia, burning mouth syndrome, carpal syndrome, glaucoma, cataracts, hypertension, and peripheral arterial disease. For therapeutic purposes, ALA is administered orally in doses of 300-1800 mg/day, and for some indications its topical and parenteral administration has been investigated. The safety of oral administration in the mentioned doses has been investigated in many clinical studies lasting from 4 months to 4 years. The effectiveness of ALA in premalignant changes of the cervix has not been investigated to date. Considering the proven effectiveness of oral supplementation with other antioxidants (such as green tea polyphenols or Se) in patients with LSIL, the aim of this research is to investigate, for the first time, the effectiveness of ALA in regression of LSIL.

The study was designed as double-blind, randomized, placebo-controlled trial where participants were asked to self-administer either 600 mg of ALA in form of 2 capsules containing 300 mg of ALA (donated by Zada Pharmaceuticals, Lukavac, Bosnia and Herzegovina) or a placebo (provided as identical oral capsules containing rice starch, also donated by Zada Pharmaceuticals) per os daily for 3 months. The research protocol for this study has been approved by the Ethics Committee of the University of Zagreb, Faculty of Pharmacy and Biochemistry and the Ethics Committee of the University Clinical Centre Tuzla. The trial was performed in accordance with the international, national, and institutional guidelines pertaining to clinical studies and biodiversity rights and it complied with the CONSORT guidelines.

At the initial appointment eligible patients were introduced to the study design. They were informed about the study protocol: aim and the purpose of the study, general methodology, expected roles of the participants, potential risks of participating in the study, potential benefits of the participation in the study, data confidentiality issues, and contact details of investigators who, when necessary, provided any kind of additionally needed information. In case patient agreed to participate in the study, they l signed informed consent form. All participants were asked to give their written informed consent for the inclusion in the study. After inclusion in the study patients filled a baseline questionnaire and provided information on basic anthropometric characteristics, reproductive history, current medication, and major lifestyle characteristics (smoking, level of physical activity). Examination of patients' eating and living habits was conducted using a standardized and validated semiquantitative food frequency questionnaire (FFQ) with the help of trained staff. Patients were advised not to change their diet during the study.

Participants were randomized in the ratio 1:1 for ALA: placebo. Patients were randomly allocated a patient number that determined their supplement allocation. They received two bottles of capsules prelabelled with their study number containing either capsules of ALA sufficient for 3 months of supplementation, or identical capsules of placebo (rice starch) sufficient for 3 months of supplementation. Patients were asked to return the remaining capsules after the 3-month period to assess the adherence. During the supplementation period participants were contacted twice by telephone by a research team member to check possible adverse effects and to improve the adherence. Compliance after enrolment was measured as the percentage of pills taken between visits. Subjects who took less than 75% of pills after randomization were considered as noncompliant and were taken off the study. 3 months after the entry participants were invited to a follow up appointment.

At both initial and follow-up appointment cytological screening, colposcopy and targeted biopsy and histological confirmation of cytological-colposcopic diagnosis wasconducted and blood samples were taken and analysed (assessment of primary and secondary outcomes of the study). The samples were collected at the Gynaecology and Obstetrics Clinic of the University Clinical Centre Tuzla over a period of 18 months. Sample analyses were conducted at the University Clinical Centre Tuzla and University of Zagreb, Faculty of Pharmacy and Biochemistry. Statistical processing, analysis and interpretation of the study results was completed within 6 months from the end of the analysis of the biological samples.

Patients' personal data, data on their lifestyle and eating habits (obtained from the FFQ) and measurements of the primary and secondary outcomes of the study were stored and processed in electronic form of the patients' registry. Data dictionary containing detailed descriptions of each variable used by the registry, including the source of the variable was developed. The registry was operated according to standard operative procedures of the University Clinical Centre Tuzla. Project manager and his associates were obliged to fully comply with the prescribed procedures for the protection of personal data. Patients' data were entered into project databases according to the initials of patients first and last name and using a special code. Their medical documentation was only reviewed by the project manager and his associates, and patients' name was never revealed to third parties. Patients' documentation was accessible to representatives of the Ethics Committee at the institution where clinical study was conducted (University Clinical Centre Tuzla) and representatives of the Committee for the Ethics of Experimental Work of the Faculty of Pharmacy and Biochemistry of the University of Zagreb, which is responsible for approving and supervising the conduct of this research.

Block randomization of patients was performed to ensure balance using an in-house computer program. To determine the sample size, a randomized clinical trial sample size formula was used, where type one (α) error was set at 5% and the study power was set at 90%. Ratio of case to control was 1, and expected dropout was 2%. LSIL wasthe main outcome of the study; expected proportion of LSIL in control group was 50%, and in the treated group 40%. Assuming a dropout 2% the target sample size has been determined to be 96 (48 subjects per group). The research results (qualification of cervical squamous epithelium lesions, parameters of inflammation, parameters of oxidative stress) was statistically processed using the MedCalc software package. The basic features of the variables were tested using descriptive analysis. The normality of data distribution was tested using the Kolmogorov-Smirnov test, and parametric or non-parametric statistical tests were used for further analysis of the results.

Effect of Alpha-lipoic Acid on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)

Effect of Alpha-lipoic Acid Supplementation on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)-Double Blind, Randomized, Placebo-controlled Trial

LSIL will be confirmed by cytological screening, colposcopic examination of the cervix and targeted biopsy and histological confirmation of cytological-colposcopic diagnosis at the study baseline and after 3 months the intervention (day 0 and day 90). The findings of cytological screenings will be qualified according to the internationally recognized form "Zagreb 2002". The colposcopic form "Rio de Janeiro-Zagreb 2011" will be used to classify the colposcopic findings. Uterine tissue samples obtained by targeted colposcopic biopsy will be processed by a standard histological method. Assessment of the pathological diagnosis will be done as blindness by a single experienced pathologist at baseline and after the 3 months of intervention. The classification of premalignant and invasive cervical squamous epithelial lesions will be determined according to the WHO Tumour Classification.

For the assessment of the secondary outcomes blood samples will be collected at baseline (day 0) and after the treatment (after 12 weeks) by venipuncture after a 10 h fasting period, aliqoted and stored at -20C for future analysis. Analyses will be conducted within 30 days from sample aquisition. The following oxidative stress parameters will be determined:

total serum antioxidant status (assessed by measuring scavenging activity against the 2,2'-azino-bis(3-ethylbenzthiazoline-6-sulfonic acid radical (ABTS+˙); oxygen radical absorbance capacity (ORAC) of the serum and ferric reducing power of the serum (FRAP)); serum malondyaldehide levels (MDA); serum reduced glutathione levels (GSH); serum superoxide dismutaze activity (SOD).

For the assessment of the secondary outcomes blood samples will be collected at baseline (day 0) and after the treatment (after 12 weeks) by venipuncture after a 10 h fasting period, aliqoted and stored at -20C for future analysis. Analyses will be conducted within 30 days from sample aquisition. The following inflammation parameters will be determined:

fibrinogen; high-sensitive C-reactive protein; sedimentation; interleukin-6

For the assessment of the secondary outcomes blood samples will be collected before and after the treatment at three months by venipuncture after a 10 h fasting period. Lipid parameters will be determined immediatelly after sample collection and include:

measurement of triglycerides; measurement of total cholesterol; measurement of high-density lipoproteins (HDL ) measurement of low-density lipoproteins (LDL )

University Clinical Center Tuzla

University of Zagreb

Prof.

Atypical Squamous Cells of the Cervix

Amino Acids

Vaccines

Glycine

Detox adjuvant

Cysteine

Prime: 3 mg pNGVL4a-Sig/E7(detox)/HSP70 DNA Boost: 0.1 mg TA-CIN protein

Prime: PBS (Phosphate Buffered Saline) Boost: PGC (Phosphate Glycine Cysteine Buffer)

pNGVL4a-Sig/E7(detox)/HSP70 (naked DNA plasmid priming vaccine) TA-CIN (HPV16 L2E7E6 fusion protein booster vaccine)

PVX-2

Placebo

Muchou J Ma, MD

Allison Blomer, MD

Mark H Einstein, MD

Kimberly A Bonar, MD

Kayla Rauch

Mark Akin, MD

Charles Kirkham, MD

Jeff M Livingston, MD

* To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen
* To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6

Safety run-in followed by randomized double-blind, placebo-controlled study

Safety run-in is open label (no control), followed by randomized double-blind, placebo-controlled study

Patients with cervical cytologic diagnosis of ASC-US, ASC-H, or LSIL

Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL

A Randomized Double-Blind, Placebo-controlled Phase II Trial With Safety Run-In of Intramuscular pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN for the Treatment of Patients With HPV16+ Atypical Squamous Cells of Undetermined Significance (ASC-US) or Cannot Exclude High Grade SIL (ASC-H) Cytology or Low-grade Squamous Intraepithelial Lesion (LSIL)

To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen

To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6

To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on maintenance of Human Papillomavirus (HPV) 16 clearance by Month 12

To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on regression to cytology with no evidence of intraepithelial lesion or malignancy (NILM) at Month 6

Parexel

PapiVax Biotech, Inc.

Infections

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Papilloma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

Neuroprotective Agents

Flavonoid

Hyaluronic Acid

Epigallocatechin gallate

Vitamin B 12

Hydroxocobalamin

Folinic Acid

Methylcobalamin

Epigallocatechin

Vitamin B12

Cobalamin

Cyanocobalamin

The patients in this group undergo treatment with Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg and Folic acid 400mcg by oral route once per day.

The patients in this group follow the routine clinical practice, namely the clinical monitoring.

Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg

EGCG, FA, HA, B12

The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.

Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.

After three months of treatment PAP-test and HPV-DNA test will be repeated.

Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.

Epigallocatechin Gallate and Other Antural Compounds in HPV Infections

Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests

The outcome consists of the number of negative DNA-test obtained in patients previously positive.

The outcome consists of the number of negative PAP-tests obtained in patients previously positive.

The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.

Centro di Ricerca Clinica Salentino

Professor

colposcopy

Jean-Jacques Baldauf, MD

Gerlinde Averous

Dominique Collin, MD

Jean-Luc Harter, MD

P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.

Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.

Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Immunohistochemical Study on Biopsies (Retrospective and Prospective Analysis) and on Liquid Based (SurePath) Cervical Cytology (Prospective Analysis). Correlation With HPV Typing and Clinical Outcome.

University Hospital, Strasbourg, France

Christine GEILLER, Directeur de la Recherche Clinique et des Innovations

Low dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

Intermediate dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

High dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

Selected dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0 and 4, and the TA-CIN protein is administered by intramuscular injection at week 8.

pNGVL4aCRTE6E7L2

TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.

TA-CIN

Wendy Wu, MS

Yung-Nien Chang, Ph.D.

Nuzhat R Siddiqui, MD

Kimberly Levinson, M.D.

Richard Roden

Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine

Primary Objectives

1. To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL.
2. To determine the appropriate intra-muscular injection dose of pNGVL4aCRTE6E7L2 DNA vaccine as determined by toxicity and immunogenicity for a subsequent phase II clinical trial.
3. To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine prime, TA-CIN protein vaccine boost in patients with persistent HPV16+ ASC-US/LSIL.

Patients with a cervical cytologic diagnosis of ASC-US or LSIL

Study of Treatment for HPV16+ ASC-US or LSIL

Phase I Clinical Trial Assessing the Safety and Feasibility of Intramuscular pNGVL4aCRTE6E7L2 and TA-CIN Administration for the Treatment of Patients With Persistent HPV16+ ASC-US or LSIL

To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL

To determine the appropriate intra-muscular injection dose of pNGVL4aCRTE6E7L2 DNA vaccine as determined by toxicity and immunogenicity for a subsequent phase II clinical trial

To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine prime, TA-CIN protein vaccine boost in patients with persistent HPV16+ ASC-US/LSIL

To evaluate the levels of circulating antibody specific for HPV-16 in the peripheral blood pre- and post-vaccination

To evaluate the levels of circulating HPV-16 E6- and E7-specific CD8+ T cells and T regulatory cells in the peripheral blood pre- and post-vaccination

To evaluate the proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2

To evaluate the presence of high risk HPV, and specifically HPV16 in cytologic specimens pre- and post-vaccination

To evaluate changes in the cytopathology of ectocervical and endocervical specimens taken pre- and post-vaccination

Johns Hopkins University

University of Alabama at Birmingham

Professor of Medicine, Division Director Gynecology Oncology

At the colposcopy clinic, vaginal self-sample will be collected with the Flocked Swab (Noble Bioscience, Inc., Korea).

Flocked Swab

Physician collected cervical sample will be collected also at the colposcopy center with the Cervical Brush (Noble Bioscience, Inc., Korea).

Cervical Brush

The hrHPV assay used, will be the Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.

HPV assay

Jae Kwan Lee, MD, Ph.D.

Hyun Woong Cho, MD

Seung-hoe Song, MBE

Ji-young Lee

Jin Hwa Hong, MD, Ph.D.

Yung Taek Ouh, MD

Hyun-Woong Cho, MD

This study is a prospective observational study of human papillomavirus (HPV) testing using urine and self-collected vaginal samples for women who have atypical squamous cells of undetermined significance(ASCUS) or low grade squamous intraepithelial lesion(LSIL) on Pap test. Among women who are diagnosed with ASCUS and LSIL, HPV test is performed by collecting urine and self-collected vaginal sample in standardized condition before colposcopy, and evaluation will be performed as a primary screening test with cytology triage.

The samples are collected from patients referred to colposcopy because of prior cervical abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on the morning of visit to the colposcopy center. At the colposcopy center, self-collected vaginal samples are taken by the patient herself with a plastic brush (Flocked Swab, manufactured by Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample with a plastic brush (Cervical Brush, manufactured by Noble Bioscience, Inc.).

Physician collected cervical samples, self-collected vaginal samples and urine samples are used to perform HPV testing with Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.

The Anyplex™ II HPV HR detection kit (manufactured by Seegene. Inc, Korea) is a new, multiplex, real-time polymerase chain reaction assay to detect individual 14 high-risk. (HR) human papillomavirus (HPV) types in a single tube.

The Roche Cobas® 4800 HPV test (manufactured by Cobas) is a novel molecular method based on real-time PCR (RT-PCR), with a fully automated system allowing quick and efficient sample processing. Cobas can detect the human papillomavirus type 16(HPV16), the human papillomavirus type 18(HPV18), 12 other high-risk HPVs (hrHPVs) (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68, as a pooled result), and the β-globin control independently in the same PCR.

Realtime HPV HR-S Detection kit (manufactured by Sejong Biomed Co, Korea) is a new, real-time polymerase chain reaction assay to detect HPV 16, HPV 18, 12 other high-risk HPVs (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68). Real-time HPV HR-S Detection Kit is based on accurate real-time PCR method as described, and it can detect 14 kinds of HPV type detection in a single test (HPV 16/18 genotype and others (UDG) -dUTP) system for the prevention of contamination, and a control agent (hemoglobin DNA, a human-derived DNA) as a whole process control was introduced into a high-risk genotype (12 genotypes other than HPV 16/18). It has high sensitivity and specificity for detection of high risk genotypes by increasing the reliability of the results.

The main goal of this study is to determine whether HPV testing using urine and self-collected sample is sensitive to detecting precancerous lesions such as cervical intraepithelial neoplasia(CIN)2/3 in patients diagnosed with ASCUS and LSIL on the Pap test. The colposcopy and histological findings will be used as the gold standard. In addition, the relative sensitivity and specificity for detecting HPV16, HPV18 and high risk HPV will be determined for each of the three HPV tests using urine and self-collected samples compared with the HPV tests using physician-collected samples.

Urine sample, vaginal self-sample and cervical cell sample collected by a gynecologist. No human DNA is extracted from the samples but the samples can contain HPV DNA.

HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study

Human Papillomavirus(HPV) Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study

Absolute sensitivity and specificity for finding underlying cervical intraepithelial neoplasia(CIN)2+ of HPV testing(Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit) on urine, self- and clinician-collected samples.

Relative sensitivity and specificity of hrHPV testing on vaginal self-samples and urine sample vs clinician-collected samples.

Concordance of the presence of HPV16, 18 and other high risk HPV genotyping results applied on urine, self- and clinician-collected samples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
oncoFISH Cervical Test for Detection of 3q26 Region Gain	NCT01416922	Cervical Cancer LSIL		21 Years -	Ikonisys, Inc.
oncoFISH Cervical Test for Detection of 3q26 Region Gain	NCT01416922	Cervical Cancer LSIL		21 Years -	Ikonisys, Inc.
Effect of Alpha-lipoic Acid on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)	NCT05485259	Low-Grade Squam...	DL-alpha lipoic... placebo (rice s...	18 Years - 55 Years	University of Zagreb
Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL	NCT03911076	ASC-US ASC-H Atypical ... LSIL	PVX-2 Placebo	25 Years - 70 Years	PapiVax Biotech, Inc.
Epigallocatechin Gallate and Other Antural Compounds in HPV Infections	NCT06098456	Papilloma-induc...	EGCG, FA, HA, B...	20 Years - 45 Years	Centro di Ricerca Clinica Salentino
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.	NCT00343213	Cervical Intrae...	colposcopy	18 Years -	University Hospital, Strasbourg, France
Study of Treatment for HPV16+ ASC-US or LSIL	NCT03913117	ASC-US LSIL	pNGVL4aCRTE6E7L... TA-CIN	19 Years -	University of Alabama at Birmingham
HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study	NCT03409471	ASC-US LSIL	Flocked Swab Cervical Brush HPV assay	20 Years - 60 Years	Korea University Guro Hospital
oncoFISH Cervical Test for Detection of 3q26 Region Gain	NCT01416922	Cervical Cancer LSIL		21 Years -	Ikonisys, Inc.

Spots Global Cancer Trial Database for lsil

Every month we try and update this database with for lsil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lsil

Every month we try and update this database with for lsil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lsil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.