The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
Public ClinicalTrials.gov record NCT03366493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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+).
Study identification
- NCT ID
- NCT03366493
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- FRD Combination Product
- Cytology Other
- HPV testing Other
- Colposcopy Procedure
- ECC Procedure
- Biospy Procedure
Combination Product · Other · Procedure
Eligibility (public fields only)
- Age range
- 20 Years to 60 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2017
- Primary completion
- Dec 6, 2018
- Completion
- Dec 6, 2018
- Last update posted
- Dec 7, 2017
2017 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Augusta University | Augusta | Georgia | 30912 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03366493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2017 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03366493 live on ClinicalTrials.gov.