The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 20 - 60 |
| Updated: | 12/10/2017 |
| Start Date: | December 7, 2017 |
| End Date: | December 7, 2018 |
| Contact: | Daron G Ferris, MD |
| Email: | DFERRIS@augusta.edu |
| Phone: | 706-721-2535 |
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical
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+).
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+).
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.
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.
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
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