200
Participants
Start Date
December 7, 2017
Primary Completion Date
December 7, 2018
Study Completion Date
December 7, 2018
FRD
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. After inserting a speculum into your vagina, the FRD™ staining solution will be applied to the cervix using an applicator. After removal of the applicator, the doctor will inspect the applicator for color changes and note any changes. The physician will then remove any excess stain from the cervix using distilled water.
Cytology
Cytology testing done by collecting samples of cells, and smearing those samples across a glass microscope slide in order to detect abnormal cells that may develop into cervical cancer.
HPV testing
HPV tests will detect HPV infections, which can lead to cervical cells to become cancer cells.
Colposcopy
During the colposcopic examination, the physician will insert a speculum into the vagina and then apply a vinegar solution to the cervix. The vinegar solution causes any potential abnormal cells to turn white. These white regions are best seen using the colposcope, which magnifiesthe skin.
ECC
If the examination is not satisfactory and the doctor is not able to see the entire cervix, he may perform an endocervical curettage, or ECC. This sample is collected by placing a long, thin instrument into the cervical canal and a sample is scraped from that area. The sample will be sent to the laboratory for a pathologist to review.
Biospy
"According to the colposcopy assessment, if the doctor sees a white area, or an area of abnormal cells, a tiny sample of tissue, called a biopsy will be taken from the cervix. About half of women do not feel the biopsy being taken.~Others may feel a quick pinch. After the biopsy, the wound will be treated to stop bleeding.The biopsy will be sent to the laboratory for a pathologist to review."
RECRUITING
Augusta University, Augusta
Lead Sponsor
GY Highland Biotech LLC
INDUSTRY