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