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

NCT03366493 | Unknown Phase 3 DMC

• 1 other identifier: GYFRD-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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+).

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3

Outcome Measures

Primary Outcomes (1)

• 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.

  2-4 weeks

Secondary Outcomes (1)

• Subjects without CIN2+ after colposcopy

  6 months - 1 year

Study Arms (3)

FRD, Cyctology, HPV testing

EXPERIMENTAL

Subjects will be asked to have the FRD, Cytology, and HPV test performed on them by the study doctor or staff.

Combination Product: FRD; Other: Cytology; Other: HPV testing

Colposcopy Examination (and ECC if necessary)

EXPERIMENTAL

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.

Procedure: Colposcopy; Procedure: ECC

Biospy

EXPERIMENTAL

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.

Procedure: Biospy

Interventions

FRD COMBINATION_PRODUCT

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.

Also known as: Folate Receptor - Mediated Staining Solution

FRD, Cyctology, HPV testing

Cytology OTHER

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.

Also known as: Pap smear

FRD, Cyctology, HPV testing

HPV testing OTHER

HPV tests will detect HPV infections, which can lead to cervical cells to become cancer cells.

FRD, Cyctology, HPV testing

Colposcopy PROCEDURE

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.

Colposcopy Examination (and ECC if necessary)

ECC PROCEDURE

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.

Also known as: Endocervical curettage

Colposcopy Examination (and ECC if necessary)

Biospy PROCEDURE

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.

Biospy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: Non-pregnant women who are sexually active and need to do a routine cervical cancer screening.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis: Patients who need to do gynecological pelvic examination
• Age and sex: Women between the ages of 20 - 65

You may not qualify if:

• 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

Sponsors & Collaborators

• GY Highland Biotech LLC: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Interventions

Cytological Techniques; Papanicolaou Test; Colposcopy

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biopsy; Cytodiagnosis; Specimen Handling; Surgical Procedures, Operative; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Daron G Ferris, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daron G Ferris, MD

CONTACT

706-721-2535; DFERRIS@augusta.edu

Mena Farag, MS

CONTACT

908-668-776; mena@gy-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: December 7, 2017
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

US (1)