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The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection

Primary Purpose

Cervical Intraepithelial Neoplasia Grade 2/3

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FRD
Cytology
HPV testing
Colposcopy
ECC
Biospy
Sponsored by
GY Highland Biotech LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Intraepithelial Neoplasia Grade 2/3

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Experimental

Arm Label

FRD, Cyctology, HPV testing

Colposcopy Examination (and ECC if necessary)

Biospy

Arm Description

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.

Outcomes

Primary Outcome Measures

Subjects diagnosed with CIN2+
The primary outcome measure of the study is when the subjects' histological diagnosis is CIN2+. At that point they can exit the study.

Secondary Outcome Measures

Subjects without CIN2+ after colposcopy
The secondary outcome measures are all women < 25 years & women ≥25 years that were not chosen to be a part of the 10% with normal cytology, negative FRD, & negative HPV. Women without CIN2+ after colposcopy will have to come back for a follow up visit in 6 months or 1 year. All patients can exit the study after colposcopy.

Full Information

First Posted
December 4, 2017
Last Updated
December 4, 2017
Sponsor
GY Highland Biotech LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03366493
Brief Title
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
Official Title
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2017 (Anticipated)
Primary Completion Date
December 7, 2018 (Anticipated)
Study Completion Date
December 7, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GY Highland Biotech LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia Grade 2/3

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FRD, Cyctology, HPV testing
Arm Type
Experimental
Arm Description
Subjects will be asked to have the FRD, Cytology, and HPV test performed on them by the study doctor or staff.
Arm Title
Colposcopy Examination (and ECC if necessary)
Arm Type
Experimental
Arm Description
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.
Arm Title
Biospy
Arm Type
Experimental
Arm Description
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 Type
Combination Product
Intervention Name(s)
FRD
Other Intervention Name(s)
Folate Receptor - Mediated Staining Solution
Intervention 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. 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.
Intervention Type
Other
Intervention Name(s)
Cytology
Other Intervention Name(s)
Pap smear
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HPV testing
Intervention Description
HPV tests will detect HPV infections, which can lead to cervical cells to become cancer cells.
Intervention Type
Procedure
Intervention Name(s)
Colposcopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ECC
Other Intervention Name(s)
Endocervical curettage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjects diagnosed with CIN2+
Description
The primary outcome measure of the study is when the subjects' histological diagnosis is CIN2+. At that point they can exit the study.
Time Frame
2-4 weeks
Secondary Outcome Measure Information:
Title
Subjects without CIN2+ after colposcopy
Description
The secondary outcome measures are all women < 25 years & women ≥25 years that were not chosen to be a part of the 10% with normal cytology, negative FRD, & negative HPV. Women without CIN2+ after colposcopy will have to come back for a follow up visit in 6 months or 1 year. All patients can exit the study after colposcopy.
Time Frame
6 months - 1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Non-pregnant women who are sexually active and need to do a routine cervical cancer screening.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daron G Ferris, MD
Phone
706-721-2535
Email
DFERRIS@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mena Farag, MS
Phone
908-668-776
Email
mena@gy-biotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daron G Ferris, MD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Goebel, BS, CCRC
Phone
706-721-8944
Email
AGOEBEL@augusta.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection

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