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HR-HPV Multi-site Opportunistic Screening in Liaoning, China

NCT03178136UNKNOWNOBSERVATIONAL

Summary

It is universally accepted that the persistent infection of high-risk human papillomavirus(HR-HPV) is the cause of cervical intraepithelial neoplasias and cancer. Some researches indicate that the virus load may relate the extent of the disease. The objective of the study is to detect the virus load of 14 types HR-HPV among the participants, using a new HPV DNA hybrid capture technology,sequentially find the diagnostic significance of virus load of HPV.

Key Facts

Lead Sponsor

Min Wang

Enrollment

10000

Start Date

2017-06-19

Completion Date

2019-06-01

Study Type

OBSERVATIONAL

Official Title

HR-HPV Multi-site Opportunistic Screening in Liaoning, China

Conditions

Cervical Cancer

Eligibility

Age Range

25 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

The patients who are voluntary to accept screening with sexual life

Exclusion Criteria:

uterectomy, cancer, other serious illness, physical examination(pregnant women are not exclusive)

Outcome Measures

Primary Outcomes

virus load

virus load of 14 types HR-HPV

Time frame: 1 day

Locations

Cancer hospital of Anshan City, Anshan, China

The second hospital of Chaoyang City, Chaoyang, China

Dalian obstetrics and gynaecology hospital, Dalian, China

The first affiliated hospital of Jinzhou Medical University, Jinzhou, China

The first hospital of China Medical University, Shenyang, China

Women's and children's hospital of Yingkou City, Yingkou, China

Shenyang women's and children's hospital, Shenyang, China

Linked Papers

2021-03-07

Diagnostic value of high‐risk human papillomavirus viral load on cervical lesion assessment and ASCUS triage

AbstractThis study aims to evaluate HR‐HPV viral load in the cervical lesion assessment and its diagnostic value on the triage of ASCUS. The three‐step protocol for cervical cancer screening was carried out in 5171 patients from June 2017 to August 2019, and 1620 histopathological results were obtained. The positive rate of HR‐HPV and TCT increased with the aggravation of pathological grades of cervical lesions. The sensitivity and specificity of HR‐HPV (DH3) to detect CIN II+ were 91.91% and 84.46%, respectively. In comparison, the corresponding results of the cytology test were 80.51% and 83.12%. HPV16/18 viral load was positively correlated with the grade of cervical lesions (p < 0.001, r = 0.321). The diagnostic efficiency of AUC by applying HPV16/18 viral load was 0.682 for the diagnosis of CIN II+. The optimal HPV16/18 viral load for predicting CIN II+ was 6.80 RLU/CO (relative light units/cut‐off), with corresponding sensitivity of 48.6%, specificity of 79.7%, and Youden index of 0.283. In the ASCUS population, viral loads were statistically different in HPV16/18 and the other 12 HR‐HPV when compared cervicitis group with CIN I group and CIN II+ group (all p < 0.05). Statistical differences were detected concerning HPV16/18 viral load, contact bleeding status, and smoking status when compared cervicitis group with CIN I group and CIN II+ group (p < 0.05), with a corresponding odds ratio of 1.004, 1.533, and 5.513, respectively. Our findings suggest that HR‐HPV viral load can be regarded as a useful tool to predict the grade of cervical lesions for ASCUS triage.ClinicalTrials.gov ID: NCT03178136.

Linked Investigators

Min Wang