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Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood

Summary

Our study is a population-based, cross-sectional study. This study is conducted to recruit cervical cancer screening participants to evaluate the application value of using high-throughput sequencing technology to detect HPV in menstrual blood for cervical cancer screening. Our study is designed as a two-phase study : Phase I : This phase, which will be preparing to recruit 5,000 participants, evaluates the accuracy of menstrual blood (MB) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+) in the general population, with a secondary objective to evaluate the Minipad as a special device to collect MB. Phase II : This phase, which will continue to recruit toward the 10,000-participant target, will evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling. This phase aims to further reduce unnecessary colposcopies while maintaining high sensitivity for CIN2+ detection.

Key Facts

Lead Sponsor

Zhongnan Hospital

Enrollment

10000

Start Date

2021-09-01

Completion Date

2025-12-31

Study Type

OBSERVATIONAL

Official Title

Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood

Conditions

Cervical Cancer

Eligibility

Age Range

20 Years – 60 Years

Sex

FEMALE

Inclusion Criteria:

1. plan to undergo cervical screening
2. with regular menstruation (21-35 days)
3. agree to participate in this study and have signed an informed consent form

Exclusion Criteria:

1. with amenorrhea or menopause
2. suffering from genital tract infection
3. refuse to participate in this study

Outcome Measures

Primary Outcomes

HPV detection in menstrual blood

In phase I: The primary aim of this study is to evaluate the accuracy of menstrual blood (MB) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+) in the general population. In phase II: The primary aim of this study is to evaluate additional molecular markers (specifically DNA methylation) to optimizeThis phase, which will continue to recruit toward the 10,000-participant target, will evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling.

Time frame: December 31, 2025

Secondary Outcomes

HPV detection in menstrual blood

The secondary objective of this study is to evaluate the accuracy of minipad as a special device for menstrual blood (MB) collection in detecting grade 2 or more cervical intraepithelial neoplasia (CIN2+) in the general population

Time frame: December 31, 2025

Locations

Department of Gynecologic Oncology, Wuhan, China

Linked Papers

2026-02-04

Testing menstrual blood for human papillomavirus during cervical cancer screening in China: cross sectional population based study

Abstract Objective To compare the diagnostic accuracy of minipad collected menstrual blood versus clinician collected cervical samples to test for human papillomavirus (HPV) in the detection of cervical intraepithelial neoplasia grade 2/3 or worse (CIN2+/CIN3+). Design Cross sectional population based study. Setting Four urban and three rural communities in Hubei Province, China. Participants 3068 women aged 20-54 years with regular menstrual cycles, enrolled between September 2021 and January 2025. Interventions HPV testing using minipad collected menstrual blood, clinician collected cervical samples, and ThinPrep cytology. Women who tested HPV positive by either collection method or by cytology (atypical squamous cells of undetermined significance or worse) were referred for colposcopy directed biopsy sampling. Main outcome measure Diagnostic accuracy for detecting CIN2+ and CIN3+. Results Among 3068 participants, minipad based HPV testing showed a sensitivity of 94.7% (95% confidence interval 80.9% to 99.1%) for CIN2+ detection, comparable to clinician based HPV testing (92.1%, 77.5% to 97.9%; P=1.00). Although minipad HPV testing showed a lower specificity than clinician HPV testing (89.1%, 88.0% to 90.2% v 90.0%, 88.9% to 91.1%; P=0.001), the negative predictive value matched that of clinician HPV testing (99.9%, 99.7% to 100.0% v 99.9%, 99.7% to 100.0%; P=1.00). Both collection methods had a similar positive predictive value (9.9%, 7.1% to 13.5% v 10.4%, 7.4% to 14.3%; P=0.82) and screening efficiency (10.1 v 9.6 referrals per CIN2+ detected; P=0.82). Conclusions Minipad collected menstrual blood showed comparable diagnostic accuracy to clinician collected cervical samples for HPV testing for detecting CIN2+ and CIN3+. Trial registration ClinicalTrials.gov NCT06082765 .

Linked Investigators

Xun Tian

Zheng Hu