Clinical trial · Interventional
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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+).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospy | Procedure | — | UNRESOLVED |
| Colposcopy | Procedure | — | UNRESOLVED |
| Cytology | Other | — | UNRESOLVED |
| ECC | Procedure | — | UNRESOLVED |
| FRD | Combination Product | — | UNRESOLVED |
| HPV testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- FRD, Cyctology, HPV testing
- description
- Subjects will be asked to have the FRD, Cytology, and HPV test performed on them by the study doctor or staff.
- interventionNames
- Combination Product: FRD
- Other: Cytology
- Other: HPV testing
- type
- EXPERIMENTAL
- label
- Colposcopy Examination (and ECC if necessary)
- description
- Subjects with abnormal cytology (≥ ASCUS/AGC), positive FRD test in either the cervix or cervical canal, and/or positive HPV test will be referred to colposcopy. Subjects with a positive FRD test for the cervical canal, unsatisfied colposcopy (type II-III), and/or detection of AGC during cytology will also have to complete an ECC procedure. In addition, 10% of the subjects who tested negative for all three tests and are ≥ 25 years old will be randomly selected to complete a colposcopy as well.
- interventionNames
- Procedure: Colposcopy
- Procedure: ECC
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis: Patients who need to do gynecological pelvic examination * Age and sex: Women between the ages of 20 - 65 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available