Trial Information

Pilots of Self-Collection Devices for HPV DNA Detection

Background:

Cytology screening programs have efficiently reduced cervical cancer incidence and mortality
in the U.S. by > 75%. However, these programs rely on the insensitive Pap smear and,
consequently, are inefficient and overly expensive. Therefore, the needs of undeserved
populations are not well-served by the current cytology-based programs for cervical cancer
screening. Based on the central role of oncogenic types of human papillomavirus (HPV)
causing virtually all cases of cervical cancer, HPV DVA testing is already approved by the
FDA as an adjunctive screening modality to cytology in this country and as a primary
screening modality internationally. A validated screening program of HPV DNA testing of
self-collected cervicovaginal specimens might provide more sensitive and wider coverage
screening than cytology in the populations underserved by cytology-based (Papanicolaou [Pap]
smear or liquid-based cytology) screening programs and therefore are at an elevated risk of
cervical cancer. We are currently evaluating self-collection devices for optimal detection
of HPV DNA, including one (POI sampler) designed by Jerry Belinson (Cleveland Clinic) and
one (Fournier device) by Arthur Fournier (University of Miami).

Objective:

To compare HPV DNA detection in cervicovaginal specimens collected using newly developed
self-collection devices, the POI sampler or the Fournier device, to HPV DNA detection in
cervicovaginal specimens collected using a Darcon swab and HPV DNA detection in
physician-directed cervical specimens.

Methods:

Two pilots will be done, one at the Cleveland Clinic with the POI sampler and one at the
University of Arizona using the Fournier device (with two different tip designs), in which
we will recruit 150 consenting women attending a colposcopy clinic, including 50 women
referred due to HSIL pap. Prior to undergoing a pelvic exam and insertion of the speculum,
the attending physician will simulate self-collection of cervicovaginal specimens using, in
alternating order, one of the new devices and a Dacron swab. After collection of the
cervicovaginal specimens, women will then undergo a standard colposcopic evaluation but with
an added cervical specimen collected from the os of the cervix to serve as the referent
standard. Specimens (n=450, 3 paired specimens per woman, for the POI sampler pilot; n =
600, 4 paired specimens per woman, for the Fournier device pilot) will be tested in a masked
fashion for oncogenic HPV DNA using Hybrid Capture 2 (HC2; Digene Corporation Gathersburg,
MD) at the NCI HPV DNA core testing facility.