Status:
UNKNOWN
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
Lead Sponsor:
GY Highland Biotech LLC
Conditions:
Cervical Intraepithelial Neoplasia Grade 2/3
Eligibility:
FEMALE
20-60 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The Folate Receptor-Mediated Staining Solution is a dye solution that stains for medical purposes used in staining cells and tissues for detecting neoplastic diseases. The main purpose of this product...
Eligibility Criteria
Inclusion
- Diagnosis: Patients who need to do gynecological pelvic examination
- Age and sex: Women between the ages of 20 - 65
Exclusion
- 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
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03366493
Start Date
December 7 2017
End Date
December 7 2018
Last Update
December 8 2017
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30912