Specimen Collection Study
Currently Enrolling Women Who Are Due for a Pap Test
We are currently conducting a clinical research study that looks at a NEW (investigational) test to detect high risk human papillomavirus (HPV), a virus associated with cervical cancer.
This test is called Alinity m HR HPV. This test can detect high risk HPV DNA in cervical cells collected using commercial liquid-based cytology (LBC) collection kits.
A women is eligible if she meets the following:
Is 25 years of age or older
Is attending our clinic for routine cervical cancer screening following screening guidelines
Has an intact cervix
Is willing and able to provide documented informed consent
Is willing and able to undergo colposcopy, biopsy, and endocervical curettage (ECC) within 12 weeks (< 84 days) from the baseline visit (if required)
Is willing and able to allow collection of 2 cervical cytology specimens
Those Who Qualify Receive:
Study related exams
FDA - Approved Pap Test
Compensation for time and travel
A women is ineligible for the study if she meets any of the following criteria:
Is pregnant at the time of visit or plans to become pregnant within the following 12 weeks
Has any known medical condition that, in the opinion of the investigator, would result in increased risk of bleeding at biopsy
Has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the last 12 months prior to baseline visit
Had a cervical cytology specimen collected within the last 4 months
Is currently participating in any diagnostic trial for cervical cancer
Had a complete or partial hysterectomy, either supra cervical or involving removal of the cervix
Is currently participating or planning to participate in any clinical trial for HPV treatment (for the duration of this study)
Previous participation in this study
What To Expect If You Participate:
The entire process to participate in the study will take about 30 - 45 minutes of your time.
Eligible participants will be asked to sign an Informed Consent Form (ICF).
After the ICF is signed, you will be asked to provide some information about yourself (e.g., demographics, specific HPV vaccine information, and gynecologic history.
Two cervical cytology specimens will be collected using liquid-based cytology collection kits.
Depending on the results from the specimens obtained, you may be required to participate in a subsequent procedure, colposcopy.
Colposcopy performed - procedure typically takes 10 - 20 minutes.
Your participation will involve only one visit and your involvement in the study will be completed UNLESS your test results are abnormal.
If abnormal cytology or high risk HPV positive results are obtained, you will be referred to colposcopy. If referred to colposcopy, your participation will end at the completion of that visit.
Pap Test Highlights
Introduced in the 1940s, Pap testing has been the single greatest contributor to the overall decline in cervical cancer.
Accurate Pap testing is even more critical in light of extended Pap testing intervals
A negative HPV test can keep patients from follow-up appointments for years
A FALSE negative HPV results can give cervical disease a chance to advance undetected
To date, ThinPrep has become the most widely used Pap test in the world, with hundreds of published, peer-reviewed studies demonstrating significant benefits over the conventional Pap smear.
ThinPrep Pap test is the first Health Canada and FDA - approved test for both Pap and HPV testing from ONE vial.
The BD SurePath liquid-based Pap test provides advantages over conventional Pap smears and other liquid-based cytology (LBC) tests, resulting in greater disease detection.
100% of cells for the lab
Increased abnormal cell detection
Reduced unsatisfactory results and patient recalls
Colposcopy is a type of cervical cancer test.
Colposcopy is a procedure to examine your cervix, vagina and vulva for signs of disease. It is a quick and easy way to find cell changes in your cervix that may turn into cancer.