drugset / Trial / NCT03366493

The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection

NCT03366493 ↗

Phase 3 Unknown 200 enrolled GY Highland Biotech LLC
RandomizedCrossoverOpen-labelScreening

Summary

The FRDTM is easy to perform and does not require sophisticated laboratory technology and/or experienced pathologists for test result interpretation. Compared to the Pap smear and HPV test, the FRDTM enables clinicians to obtain test results immediately (within 60 seconds) after the screening. This empowers clinicians in making timely decisions on appropriate patient management, and facilitating patient compliance with follow-up procedures. In addition, the FRDTM requires minimal training and technical support. Due to its advantage of rapid visualization of abnormal cervical lesions (CIN2+) in a cost-effective way, health care professionals can make cervical cancer detection accessible to women worldwide, especially in regions with limited medical resources. This is a cross-sectional study to evaluate the clinical performance of Folate Receptor-Mediated Epithelium Staining (FRDTM) in detecting cervical neoplastic lesions (CIN2+).

Timeline

Start
2017-12-07
Primary completion
2018-12-07
Completion
2018-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject FRD Diagnostic / imaging agent — Other