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

Status unconfirmed · Phase 3

Conditions studied: Cervical Intraepithelial Neoplasia Grade 2/3

In brief

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+).

Key facts

Study ID

NCT03366493

Run by

GY Highland Biotech LLC

People needed

200

Starts

2017-12-07

Expected to finish

2018-12-07

Last updated by the study team

2017-12-08

Who can join

Age: 20 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis: Patients who need to do gynecological pelvic examination
• Age and sex: Women between the ages of 20 - 65

You may not qualify if…

• Women with total hysterectomy
• Women who have done cervical surgeries, including physiotherapy of conization, LEEP, infrared ray, and microarray
• Women with serious cervical contact bleeding
• Women who are pregnant or menstrual period before the examination
• Women with acute inflammation of cervix and/or vagina
• Women who were already diagnosed with CIN2+
• Women who are taking an oral and/or injection of anti-cancer drugs

Where it is running

• Augusta University — Augusta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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