Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Dysplasia

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

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

Participants received three IM injections of 6 milligram (mg) (in 1 milliliter \[mL\]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

VGX-3100

1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

Placebo

Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.

Electroporation (EP)

Jeffrey Skolnik, MD

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) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or LSIL.

Participants with no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment.

Participants with no histologic evidence of cervical HSIL, squamous atypia, and LSIL, no evidence of HPV-16 and/or HPV-18 by type specific HPV testing at the Week 36 time, and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment.

Participants with no histologic evidence of cervical Adenocarcinoma in situ or cervical carcinoma at the Week 36 timeframe relative to baseline and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered as responders.

Participants with no evidence of HPV-16 and/or HPV-18 on specimens from noncervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 time frame were considered as responder.

A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.

Assessment of cellular immune activity occurred via the application of the Interferon-γ enzyme-linked immunosorbent spot (IFN-γ ELISpot). Peripheral blood mononuclear cells (PBMCs) isolated from whole blood sample were used for analysis.

Assessment of cellular immune activity was measured using the application flow cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examines the following external cellular markers: CD3, CD4, CD8 (T cell identification), CD137, CD38 and CD69 (T cell activation markers) as well as PD-1 (exhaustion/activation marker). Here change from baseline in CD8+CD137+Perforin+, CD8+CD38+Perforin+ and CD8+CD69+Perforin+ are reported.

Inovio Pharmaceuticals

Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.

Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

VGX-3100 + Electroporation (EP)

Placebo + EP

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Multiple

Missing

Race/Ethnicity, Customized

ITT population included all participants who were randomized.

Study Director

Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples

Number of Participants with any AE

Number of Participants with any SAE

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study

Percentage of Participants With No Evidence of Cervical HSIL on Histology

Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing

Percentage of Participants With No Evidence of LSIL or HSIL on Histology

Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18

Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma

Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations

HPV-16 E7 at Week 15

HPV-16 E7 at Week 36

HPV-18 E7 at Week 15

HPV-18 E7 at Week 36

mITT population included all participants who received at least one dose of clinical trial treatment and who had the analysis endpoint of interest. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations

HPV-16 E6: Baseline

HPV-16 E6: Change from Baseline at Week 15

HPV-16 E6: Change from Baseline at Week 36

HPV-16 E7: Baseline

HPV-16 E7: Change from Baseline at Week 15

HPV-16 E7: Change from Baseline at Week 36

HPV-18 E6: Baseline

HPV-18 E6: Change from Baseline at Week 15

HPV-18 E6: Change from Baseline at Week 36

HPV-18 E7: Baseline

HPV-18 E7: Change from Baseline at Week 15

HPV-18 E7: Change from Baseline at Week 36

Change From Baseline in Interferon-Gamma Response Magnitude

CD8+CD137+Perforin+: Baseline

CD8+CD137+Perforin+: Change from Baseline at Week 15

CD8+CD38+Perforin+: Baseline

CD8+CD38+Perforin+: Change from Baseline at Week 15

CD8+CD69+Perforin+: Baseline

CD8+CD69+Perforin+: Change from Baseline at Week 15

Change From Baseline in Flow Cytometry Response Magnitude

Overall Study

Immune System Diseases

Infections

Symptoms and General Pathology

Autoimmune Diseases

Chronic Disease

Communicable Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Antibodies

Vaccines

Immunoglobulins

subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.

subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.

LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

Liquid-based cytology (LBC) sampling

Blood samples will be collected at Months 36 and 48 for antibody determination

Blood sampling

GSK Clinical Trials

This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 36 and 48. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).

Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

Long-term Extension Study of the Efficacy of the 580299 Vaccine in the Prevention of HPV-16 and/or HPV-18 Associated Cervical Intraepithelial Neoplasia (CIN) in Japanese Women Vaccinated in the Primary Vaccination Study NCT00316693

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC).

Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR).

For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC).

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC.

HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC.

HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (\>300 days).

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Persistent infection: subjects with at least 2 positive samples (difference \> than 300 days) and no negative samples in between.

HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.

Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

NOCDs included autoimmune diseases, diabetes mellitus.

MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.

Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).

GlaxoSmithKline

The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.

Cervarix Group

Aimmugen Group

Japanase women aged 20 to 25 years at the time of first vaccination in the primary study NCT00316693

GSK Response Center

CIN1+ HPV-16/18 (N=332;335)

CIN1+ HPV-16 (N=286;289)

CIN1+ HPV-18 (N=294;291)

The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.

Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.

ASC-US+ HPV-16/18 (N=332;335)

ASC-US+ HPV-16 (N=286;289)

ASC-US+ HPV-18 (N=294;291)

The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.

Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.

The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.

Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.

Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.

Incident infection HPV-16/18 (N=332;335)

Incident infection HPV-16 (N=286;289)

Incident infection HPV-18 (N=294;291)

Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.

The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.

Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.

Persistent infection HPV-16/18 (N=257;241)

Persistent infection HPV-16 (N=225;206)

Persistent infection HPV-18 (N=227;209)

Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.

Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.

HPV-16 >=8 EL.U/mL [at Month 0] (N=282)

HPV-16 >=8 EL.U/mL [at Month 12] (N=291)

HPV-18 >=7 EL.U/mL [at Month 0] (N=281)

HPV-18 >=7 EL.U/mL [at Month 12] (N=290)

The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.

Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.

HPV-16 [Month 0] (N=282)

HPV-16 [Month 12] (N=291)

HPV-18 [Month 0] (N=281)

HPV-18 [Month 12] (N=290)

The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.

HPV-16 and HPV-18 Antibody Titers

The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.

Number of Subjects Reporting Serious Adverse Events (SAEs).

Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.

Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.

Number of Subjects With Medically Significant Conditions (MSCs).

Live infant No ACA

Live infant CA

Elective termination No ACA

Spontaneous abortion No ACA

Stillbirth No ACA

Ectopic pregnancy

Lost to follow-up

Pregnancy ongoing

Number of Subjects With Pregnancies and Pregnancy Outcomes.

Uterine Cervical Neoplasms

Papilloma

Virus Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Background:

- Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection for cervical cancer screening of underserved women. Two low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3 hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing for HPV. Researchers are interested in evaluating both tests to determine the best strategy for HPV testing of women who live in rural or underserved areas that have a high prevalence of cervical cancer diagnoses.

Objectives:

* To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting cervical cancer and precancerous lesions.
* To evaluate the best low-cost test or combination of tests for women who have been referred for cervical cancer screening or treatment.
* To compare the clinical performance of self-collected specimens versus clinician-collected specimens in detecting cervical cancer and precancerous lesions.

Eligibility:

- Women between 25 and 65 years of age who live in rural China.

Design:

* This study involves an initial testing visit and a 1-year followup visit for a high-risk subgroup.
* Participants will have the HPV E6 test, careHPV, and a visual inspection test for cervical cancer. For comparison, participants will also have the standard HPV test approved by the U.S. Food and Drug Administration.
* Participants who test positive for HPV on any of the above tests will also have colposcopy to collect samples of cervical tissue for further study.
* A random sample of women who test negative for HPV will also have colposcopy. Participants may also have biopsies if there is visual evidence of cervical abnormalities.
* At the 1-year followup visit, participants in the high-risk subgroup will have the same tests as in the previous visit..

Low-cost, molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection with acetic acid (VIA) for cervical cancer screening of underserved women. Two low-cost molecular tests for human papillomavirus (HPV) have been developed: 1) AVantage HPV E6 Test (Arbor Vita Corporation, Sunnyvale, CA, USA) ( HPV E6 Test ) detects E6 oncoproteins from HPV16, 18, and 45 and 2) careHPV (Qiagen, Gaithersburg, MD, USA) detects the DNA for a pool of 14 carcinogenic HPV genotypes. The HPV E6 Test will be ready for the first clinical evaluations in 2010. The HPV E6 Test works like an ELISA in strip format such that it takes less than two hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing. careHPV, a batch HPV DNA test that takes 2.5 hours to perform, has already been developed and is currently being used in demonstration projects. The results to date for careHPV are promising. As our primary objective, we wish to evaluate both tests, and to evaluate the best low-cost triage strategies for careHPV-positive results in areas of high prevalence of carcinogenic HPV DNA. A study of 7,500 women, ages 25-65 years, identified from an age- and region-stratified sample of women living in rural China will be conducted. All women will be screened at enrollment, and a high-risk subgroup at the one-year follow-up, by the following tests: HPV E6 Test, careHPV, and visual inspection with acetic acid (VIA). Women will also be screened at enrollment, and a high-risk subgroup at the one-year follow-up, using the digene HC2 HPV DNA Test TM ( HC2 ) (formerly known as Hybrid Capture 2)(Qiagen), the first U.S. Food and Drug Administration-approved HPV test and the gold standard for clinical HPV testing. At both time points, all screen-positive women will be evaluated by colposcopy using a rigorous diagnostic protocol. A random sample of screen negatives will undergo colposcopy but will only undergo biopsies if there is visual evidence of cervical epithelial abnormalities. careHPV-positive specimens will be tested for most carcinogenic HPV genotypes, HPV16, HPV18, and HPV45 using careHPV16/18/45. This triage test utilizes the same test platform as careHPV but screens only for those 3 carcinogenic HPV genotypes. The primary goals are 1) to evaluate the clinical performance of careHPV, the HPV E6 Test, and VIA for detection of cervical precancer and cancer and 2) to determine the positive predictive values of VIA, the HPV E6 Test, and HPV16/18/45 detection by careHPV16/18/45 for cervical precancer and cancer among careHPV-positive women.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)	NCT03185013	Cervical Dyspla... Cervical High G... HSIL	VGX-3100 Placebo Electroporation...	18 Years -	Inovio Pharmaceuticals
Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study	NCT00929526	Infections, Pap...	Liquid-based cy... Blood sampling	20 Years - 25 Years	GlaxoSmithKline
Low-Cost Molecular Cervical Cancer Screening Study	NCT01231945	DNA Probes E6 Protein Uterine Cervica... HPV		25 Years - 65 Years	National Institutes of Health Clinical Center (CC)
Trial23 - A Method Study on Cervical Screening in Women Offered HPV-vaccination as Girls	NCT03049553	Cervical Intrae...	Cobas HPV-DNA t...	23 Years - 23 Years	University of Copenhagen
Low-Cost Molecular Cervical Cancer Screening Study	NCT01231945	DNA Probes E6 Protein Uterine Cervica... HPV		25 Years - 65 Years	National Institutes of Health Clinical Center (CC)
The Effect of Physical Activity and Abstain From Smoking on the Precancerous Lesion	NCT03093623	Cancer Cervix U... Precancerous Le... Smoking	Physical activi...	20 Years - 70 Years	Taipei Medical University
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)	NCT03185013	Cervical Dyspla... Cervical High G... HSIL	VGX-3100 Placebo Electroporation...	18 Years -	Inovio Pharmaceuticals
The Effect of Physical Activity and Abstain From Smoking on the Precancerous Lesion	NCT03093623	Cancer Cervix U... Precancerous Le... Smoking	Physical activi...	20 Years - 70 Years	Taipei Medical University
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System	NCT00973362	Human Papilloma...	APTIMA HPV Assa... FDA-Approved HP...	21 Years -	Gen-Probe, Incorporated
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)	NCT03721978	Cervical Dyspla... Cervical High G... HSIL	VGX-3100 Placebo CELLECTRA™-5PSP	18 Years -	Inovio Pharmaceuticals

Spots Global Cancer Trial Database for cervical intraepithelial neoplasia (cin)