The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
Cervical Intraepithelial Neoplasia Grade 2/3
About this trial
This is an interventional screening trial for Cervical Intraepithelial Neoplasia Grade 2/3
Eligibility Criteria
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
Sites / Locations
- Augusta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
FRD, Cyctology, HPV testing
Colposcopy Examination (and ECC if necessary)
Biospy
Subjects will be asked to have the FRD, Cytology, and HPV test performed on them by the study doctor or staff.
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.
According to the colposcopy assessment, if the results show satisfied (type I) then a biopsy will be taken. Finally, a histopathological examination will be done and used as the gold standard. Subjects with a histopathological examination result of < CIN2 will be asked to come back for a follow up visit within 6 months or 1 year, according to the investigator's discretion.