The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- GY Highland Biotech LLC
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Subjects diagnosed with CIN2+
Study Overview
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 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+).
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 is to detect abnormal cervical lesions (CIN2+) during a gynecological speculum examination. Therefore, the purpose of this study is to evaluate the clinical performance of Folate Receptor-Mediated Epithelium Staining (FRDTM) in detecting cervical neoplastic lesions (CIN2+).
The subjects who are enrolled in this study will first undergo the FRD test, then cytology and HPV test. Women 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. 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. Subjects with a positive FRD test for the cervical canal, unsatisfied colposcopy (type II-III), and/or detection of AGC during cytology will have to complete an ECC procedure as well. 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. Subjects can exit the study at any time after colposcopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
FRD, Cyctology, HPV testing
Subjects will be asked to have the FRD, Cytology, and HPV test performed on them by the study doctor or staff.
Intervention: Cytology (Other)
FRD, Cyctology, HPV testing
Subjects will be asked to have the FRD, Cytology, and HPV test performed on them by the study doctor or staff.
Intervention: FRD (Combination Product)
FRD, Cyctology, HPV testing
Subjects will be asked to have the FRD, Cytology, and HPV test performed on them by the study doctor or staff.
Intervention: HPV testing (Other)
Colposcopy Examination (and ECC if necessary)
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.
Intervention: Colposcopy (Procedure)
Colposcopy Examination (and ECC if necessary)
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.
Intervention: ECC (Procedure)
Biospy
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.
Intervention: Biospy (Procedure)
Outcomes
Primary Outcomes
Subjects diagnosed with CIN2+
Time Frame: 2-4 weeks
The primary outcome measure of the study is when the subjects' histological diagnosis is CIN2+. At that point they can exit the study.
Secondary Outcomes
- Subjects without CIN2+ after colposcopy(6 months - 1 year)