Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Immune System Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Papillomavirus Infections

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

Genital Diseases

Urogenital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

DNA Virus Infections

Tumor Virus Infections

Women with perinatally acquired HIV aged 18 or over who are sexually active

Women with perinatally acquired HIV aged 18 or over who are not sexually active

HPV test from cervical sample using Cepheid GeneXpert HPV

Human papillomavirus testing

Cervical cytology

HPV type specific serology (16/18) using ELISA from serum samples

HPV serology

Tamara Elliott

Sarah Fidler

This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.

This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling (n=50) or (2) non-sexually active women, blood sampling only (n=30). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.

Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV

Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV

Public Health England

Imperial College London

Endometrial Neoplasms

The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation.

DNA methylation testing

Lei Li, M.D

Lei Li, MD

Lei Li, M.D.

Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for endometrial screening. Four hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 7150 patients.

Host DNA CDO1 and CELF4 methylation testing in cervical cytology

DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening

The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials

Sensitivity of methylation testing of cervical cytology compared with histology

Specificity of methylation testing of cervical cytology compared with histology

Positive predictive value of methylation testing of cervical cytology compared with histology

Negative predictive value of methylation testing of cervical cytology compared with histology

Obstetrics & Gynecology Hospital of Fudan University

The Third Xiangya Hospital of Central South University

Women's Hospital School Of Medicine Zhejiang University

Lei Li

Professor

Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)

Self-sampling device for cervical vaginal lavage

Delphi Screener

Carolyn Westhoff, MD

The aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions.

The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.

Feasibility of Delphi Screener for Cervical Cytology

The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City

We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.

The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints.

Kappa comparing clinician-collected cytology result to self-lavage cytology result

On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening

Delphi Devices BV

Columbia University

Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)

Single Arm Study

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Heidi Jones

sensitivity

specificity

Single Arm Study of Delphi Screener

Sensitivity and Specificity

For acceptability, 197 women used the device; 30 of these women did not have valid gold standard results but did respond to acceptability, thus for acceptability endpoint the sample size is 197 (while the sample size is 167 for sensitivity, specificity and kappa analyses due to insufficient sepcimens /loss to follow-up for colposcopy).

Outcome: Acceptability of Device

Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)

All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room.

Kappa Coefficient

Overall Study

Skin and Connective Tissue Diseases

Recurrence

Papilloma

Warts

Condylomata Acuminata

Skin Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

All Drugs and Chemicals

Vaccines

Immunologic Factors

Three doses of 4 HPV vaccine is given at registered intervals.

Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.

Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

Quadrivalent HPV vaccine

Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

Hepatitis B vaccine

Greta G Dreyer, MMed(O&G)PhD

Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in South Africa. Medical and destructive therapy for small warts is generally very effective, however unique problems posed by large or extensive genital warts are not so easily solved and treatment of affected patients remains very challenging. Recurrences are common especially among immune-compromised women. This study will test whether giving the quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment with HPV vaccine can play a role in the control of both malignant and benign HPV disease in women with and without HIV infection through stimulation of the antibody response. In addition, HPV types and other associated diseases will be studied in women receiving HPV vaccine and placebo.

Patient selection:

Female patients referred or presenting with genital warts at each site will be eligible and evaluated against the inclusion and exclusion criteria.

Women who are clinically or severely immune-compromised will not be included into the study, but both HIV negative and HIV infected women will be included. Seventy-five women with large or recurrent genital warts will be recruited for this study from 2 sites in South Africa.

Recruitment:

Women with genital warts will be evaluated for inclusion into the study. Those who fit the inclusion criteria and are without any of the exclusion criteria will be fully informed and invited to participate. The first target will be to recruit the first seventy-five consecutive eligible patients who have signed written consent; recruitment for the study will be done for at least 24 months.

First clinical visit:

* Evaluation genital lesions:

On study entry tumour size and position will be documented graphically and photographically and viral typing from the vulva wart and cervix will be done using Roche Linear Array test.

* Evaluation immune status:

HIV status and CD 4/CD 8 count will be recorded and tested and the serum will be collected for antibody testing. Cervical disease of clinical significance will be excluded or treatment offered if relevant.

* Randomization:

Patients will be randomized to receive either quadrivalent HPV or Hepatitis B vaccine.

* Vaccination:

The participants assigned to the test group will be administered quadrivalent HPV vaccine in three doses as recommended by the manufacturer. Participants assigned to the control group will receive Hepatitis B vaccine in three doses as recommended by the manufacturer.

Follow-up clinical visits: week 8, week 16 and week 24:

* Evaluation genital lesions:

Three follow up visits will be scheduled two months apart at which time the lesion size will be recorded.

* Evaluation immune status:

After month 6 or the third visit, the serum will again be collected for antibody level testing.

* Treatment decision:

According to the clinical response as measured at month six and onwards, locally destructive or surgical treatment will be allowed according to the preference of the clinician and as determined by clinical factors.

Follow up after treatment:

* Follow up will be done at six monthly intervals.
* Evaluation genital lesions:

At these visits lesion size will be determined and documented. HPV typing on the cervical and vulval lesions will be repeated at least once.

* Further treatment of warts:

If needed, repeat surgery and/or local destruction will be allowed and documented. These will be around week 48 and week 72, or study exit

Study exit:

* Participants will exit the study in week 72.
* In the absence of harm as determined at interim analysis or suggested by participant disease history, researchers will be unblinded for participant status at study exit and alternative vaccines will be offered to each of these women.

Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts

Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts

University of Stellenbosch

University of Pretoria

All eligible participants consenting to participate the study.

Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

Ming Wu, M.D.

Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.

In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.

In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.

In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.

Cell-free DNA Methylation for Endometrial Cancer

Cell-free DNA Methylation for the Diagnosis and Monitoring of Endometrial Cancer: The Training and Validation Sets in China

The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients

The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value

Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.

Host DNA Methylation for Endometrial Cancer Screening

The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center Cohort Study

Beijing Qiyuanjuhe Biotechnology Co., Ltd

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Cervical Intraepithelial Neoplasia

This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. The diagnostic values of different screening strategies were compared based on the results of cervical histology. The primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (CIN2) or more severe lesions (CIN2+). The secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for CIN2+.

Cervical exfoliated cells collected by pap smear or by Thinprep cytology testing

Cervical Cancer Screening Strategies

A Retrospective Cohort Study on the Effectiveness of Various Screening Strategies for Uterine Cervical Cancer

CIN2+ detected by various screening methods

Invasive procedures needed according to the screening results

VaIN detected by various screening methods

VIN detected by various screening methods

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV	NCT04587050	HIV Infections Human Papilloma... Cervical Cancer	Human papilloma... Cervical cytolo... HPV serology	18 Years -	Imperial College London
Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV	NCT04587050	HIV Infections Human Papilloma... Cervical Cancer	Human papilloma... Cervical cytolo... HPV serology	18 Years -	Imperial College London
DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening	NCT05290922	Endometrial Can... Cancer Screenin... DNA Methylation Testing Accurac... Cervical Cytolo...	DNA methylation...	18 Years -	Peking Union Medical College Hospital
Feasibility of Delphi Screener for Cervical Cytology	NCT00702208	Cervical Neopla...	Delphi Screener	18 Years -	Columbia University
Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts	NCT02750202	Genital Warts	Quadrivalent HP... Hepatitis B vac...	16 Years -	University of Pretoria
Cell-free DNA Methylation for Endometrial Cancer	NCT04651738	Endometrial Can... Liquid Biopsy DNA Methylation Cervical Cytolo... Diagnostic Accu... Training Set Validation Set	DNA methylation...	18 Years -	Peking Union Medical College Hospital
Host DNA Methylation for Endometrial Cancer Screening	NCT05290415	Cancer Screenin... Endometrial Can... DNA Methylation Cervical Cytolo... Liquid Biopsy Cohort Study	DNA methylation...	18 Years -	Peking Union Medical College Hospital
Cervical Cancer Screening Strategies	NCT05309122	Cervical Cancer Cervical Intrae... Human Papilloma... Cervical Cytolo... Cancer Screenin...		18 Years -	Peking Union Medical College Hospital
Cervical Cancer Screening Strategies	NCT05309122	Cervical Cancer Cervical Intrae... Human Papilloma... Cervical Cytolo... Cancer Screenin...		18 Years -	Peking Union Medical College Hospital
DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening	NCT05290922	Endometrial Can... Cancer Screenin... DNA Methylation Testing Accurac... Cervical Cytolo...	DNA methylation...	18 Years -	Peking Union Medical College Hospital
Cell-free DNA Methylation for Endometrial Cancer	NCT04651738	Endometrial Can... Liquid Biopsy DNA Methylation Cervical Cytolo... Diagnostic Accu... Training Set Validation Set	DNA methylation...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for cervical cytology