The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
NCT ID: NCT03366493
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2017-12-07
2018-12-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 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.
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 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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age and sex: Women between the ages of 20 - 65
Exclusion Criteria
* 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
20 Years
60 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GY Highland Biotech LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daron G Ferris, MD
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Augusta University
Augusta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Angela Goebel, BS, CCRC
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GYFRD-001
Identifier Type: -
Identifier Source: org_study_id