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Primary Cervical Cancer Screening by Self-sampling HPV Test

NCT05613283Active, Not RecruitingOBSERVATIONAL

Summary

Cervical cancer seriously threatens women's health and HPV infection is the main cause of cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated cell samples collected by health care provider, which is labor consuming and the coverage and compliance are both relatively low in some areas. Non-invasive hrHPV self-sampling test appears to be more acceptable and may improve the HPV screening coverage. This study aims to evaluate the clinical performance of a newly developed urine/vaginal self-sampling hrHPV test in Cervical cancer screening.

Key Facts

Lead Sponsor

Peking University People's Hospital

Enrollment

17875

Start Date

2022-11-19

Completion Date

2026-07-01

Study Type

OBSERVATIONAL

Official Title

Primary Cervical Cancer Screening by Self-sampling HPV Test

Conditions

Human Papillomavirus InfectionCervical CancerNegative For Intraepithelial Lesion Or MalignancyAtypical Squamous Cells of Undetermined SignificanceAtypical Squamous CellsCannot Rule Out High-grade Squamous Intraepithelial LesionCervical Squamous Intraepithelial LesionLow-Grade Squamous Intraepithelial LesionsHigh-Grade Squamous Intraepithelial LesionsCervical Intraepithelial Neoplasia Grade ICervical Intraepithelial Neoplasia Grade IICervical Intraepithelial NeoplasiaGrade IIIAtypical Glandular CellsAtypical Glandular Cells Not Otherwise SpecifiedAtypical Glandular CellsFavor NeoplasticCervical Squamous Cell CarcinomaAdenocarcinoma in SituCervical Adenocarcinoma

Eligibility

Age Range

21 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* a. Females aged 21-65; b. have a history of sexual life; c. The patients were voluntarily enrolled and signed the informed consent.

Exclusion Criteria:

* Accuracy Verification:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
4. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

   * Primary screening use:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
4. Those with known history of cervical cancer.
5. Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months.
6. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

Outcome Measures

Primary Outcomes

Accuracy verification

Calculate the positive coincidence rate, negative coincidence rate, total coincidence rate, and Kappa value of the comparison reagents and calculate the 95% confidence interval to verify the accuracy of detecting HPV infection.

Time frame: 2023/12

Clinical validity verification

The consistency of HPV detection of different sample types was analyzed, and the absolute risk value, relative risk value and 95% confidence interval of the development of ≥CIN2 in different primary screening types were calculated and used to verify the safety and effectiveness of the intended use of cervical cancer primary screening.

Time frame: 2027/06

Locations

Peking University People's Hospital, Beijing, China

Henan Cancer Hospital, Zhengzhou, China

The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China

Hunan Provincial Maternal and Child Health Care Hospital, Changsha, China

Chengdu Women's and Children's Central Hospital, Chengdu, China

Women's Hospital School Of Medicine Zhejiang University, Hangzhou, China

Linked Papers

2021-10-07

Accuracy of human papillomavirus tests on self-collected urine versus clinician-collected samples for the detection of cervical precancer: a systematic review and meta-analysis

The human papillomavirus (HPV) test is an effective screening tool to prevent cervical cancer. Urinary sampling for HPV detection improves the accessibility and participation of screening services and reduces the cost and burden on physicians. The clinical accuracy of urinary HPV test has yet to be determined via meta-analysis. This study assessed the clinical accuracy of these tests to detect cervical intraepithelial neoplasia (CIN) 2 or worse. Relevant studies were identified using the PubMed, Embase, and Cochrane databases. Research eligibility was based on the clinical accuracy of HPV test on clinician-collected samples as a comparator test, and urine as an index test. The reference standard was the presence of CIN2 or worse. The pooled absolute, relative sensitivity, and specificity of the urinary HPV test versus clinician-collected samples were assessed using a bivariate model. The pooled sensitivity of urinary HPV test was significantly lower than that of clinician-collected samples (ratio=0.84, 95% confidence interval [CI]=0.78-0.91). However, some polymerase chain reaction (PCR)-based HPV test such as GP5+/6+ (relative sensitivity=0.98, 95% CI=0.91-1.05), SPF10 (relative sensitivity=0.98, 85% CI=0.88-1.08) and non GP5+/6+ PCR (relative sensitivity=1.00, 95% CI=0.88-1.14) showed similar sensitivity in both the urine and clinician-collected samples. Our findings indicate that HPV test with some PCR-based assay on urine versus clinician-collected samples demonstrate similar clinical accuracy to detect CIN2 or worse. It suggests that urinary HPV test may present itself as a decent alternative screening tool for the detection of cervical pre-cancer. PROSPERO identifier: CRD42021227901.

2021-08-04

Self-collection for HPV-based cervical screening: a qualitative evidence meta-synthesis

Abstract Background Cervical cancer is the fourth most common cancer affecting women worldwide, with 85% of the burden estimated to occur among women in low and middle-income countries (LMICs). Recent developments in cervical cancer screening include a novel self-collection method for the detection of oncogenic HPV strains in the collected samples. The purpose of this review is to synthesise qualitative research on self-collection for HPV-based testing for cervical screening and identify strategies to increase acceptability and feasibility in different settings, to alleviate the burden of disease. Methods This review includes qualitative studies published between 1986 and 2020. A total of 10 databases were searched between August 2018 and May 2020 to identify qualitative studies focusing on the perspectives and experiences of self-collection for HPV-based cervical screening from the point of view of women, health care workers and other key stakeholders (i.e., policymakers). Two authors independently assessed studies for inclusion, quality, and framework thematic synthesis findings. The Socio-Ecological Model (SEM) was used to synthesize the primary studies. Results A total of 1889 publications were identified, of which 31 qualitative studies were included. Using an adapted version of SEM, 10 sub-themes were identified and classified under each of the adapted model’s constructs: (a) intrapersonal, (b) interpersonal, and (c) health systems/public policy. Some of the themes included under the intrapersonal (or individual) construct include the importance of self-efficacy, and values attributed to self-collection. Under the intrapersonal construct, the findings centre around the use of self-collection and its impact on social relationships. The last construct of health systems focuses on needs to ensure access to self-collection, the need for culturally sensitive programs to improve health literacy, and continuum of care. Conclusion This review presents the global qualitative evidence on self-collection for HPV-based testing and details potential strategies to address socio-cultural and structural barriers and facilitators to the use of self-collection. If addressed during the design of an HPV-based cervical cancer screening testing intervention program, these strategies could significantly increase the acceptability and feasibility of the intervention and lead to more effective and sustainable access to cervical screening services for women worldwide.

2019-09-30

Comparison of the performance of paired urine and cervical samples for cervical cancer screening in screening population

AbstractThe main objective of this work is to determine the performance of urine for human papillomavirus (HPV) detection in cervical cancer screening in screening population. Paired urine and cervical samples were collected from 2038 women (careHPV group: 1002, cobas4800 group: 1036) in 2015. Urine was tested by a new urine‐based HPV test and cervical samples by careHPV or cobas4800 HPV test. Women were triaged based on cervical results and then referred to colposcopy with biopsy as clinically indicated. In 2017, women were followed up and screened with cotesting strategy, women with any positive would be referred and biopsied if necessary. In careHPV group, the HPV prevalence of urine was 14.1%, and 16.4% for cervical samples. In cobas4800 group, it was 19.1% and 20.4%, correspondingly. The concordance of urine samples compared with cervical samples was moderate (careHPV group: 86.6%; κ = 0.48; cobas4800 group: 83%; κ = 0.46). The baseline sensitivity and specificity for urine against CIN2+ detection were 85.7%, 86.8% in careHPV group, and 69.2%, 82.3% in cobas4800 group, respectively. Cervical samples were 100% sensitive for both tests (careHPV and cobas4800) and 85.2% specific in careHPV group and 81.9% specific in cobas4800 group, respectively. The corresponding cumulative sensitivity and specificity were 68.8% and 87.1%, 58.8% and 81.9%, 87.5% and 85.5%, and 94.1% and 81.4%. Urine demonstrated certain potential in cervical cancer screening and could be an alternative if no better screening strategies available.

Linked Investigators

Fanghui Zhao

Hawa Camara

Hyun-Woong Cho

Jae Kwan Lee

Jin Hwa Hong

Sung Ryul Shim

Ph.D. of Epidemiology and Medical Informatics in Public Health / M.P.H.(Master of Environmental Health science in Public Health)