Pilots of Self-Collection for HPV DNA Detection
Pilots of Self-Collection for HPV DNA Detection
This study will evaluate a method of testing for human papillomavirus (HPV) DNA. For women
 who have had Pap test results that are abnormal, a new test can be done for HPV, that is,
 viruses that sometimes cause bumpy or flat warts. Such infections all usually disappear by
 themselves in 1 or 2 years if someone's Pap test shows a mild abnormality. But if the HPV
 does not go away, the infection can slowly lead to cancer of the cervix. Through this study,
 researchers will examine patients in conjunction with a colposcopy, that is, a diagnostic
 tool to determine the cause of abnormal Pap test results. The researchers hope to improve on
 the efficiency of detecting HPV and reducing the risk of cervical cancer.

 Patients ages 21 and older who are not pregnant and who have not had a hysterectomy and who
 are attending a colposcopy clinic may be eligible for this study. This study will enroll 150
 patients. Two pilot studies will be done: one at the Cleveland Clinic, with the use of the
 POI sampler (Preventive Oncology International ) and the other at the University of Arizona,
 with the use of the Fournier sampler.

 In the study part that uses the POI sampler, patients will be recruited from the existing
 colposcopy schedule. For the Fournier sampler, patients will be recruited as they attend
 their scheduled colposcopy visit. During the procedure, the doctor will collect two
 (Cleveland Clinic) or three (University of Arizona) specimen from the patients while the
 patients are sitting. A speculum is not placed in the vagina at that time. Then the doctor
 will conduct a routine pelvic exam, with the use of a speculum, while the patients are lying
 down, and perform the colposcopy. One final specimen will be collected before the the
 colposcopic evaluation. Those three or four specimens will be used just for research
 purposes, and they make up the only part different from the regular colposcopy exam. The
 pelvic exams may sometimes be slightly uncomfortable, and patients may have temporary vaginal
 spotting of blood afterward. The collection of additional specimens may also cause slight
 discomfort.

 The research specimens, which will not be labeled with information that directly identifies
 the patients, will be stored at a repository sponsored by NIH. Those specimens would be
 tested now or in the future.

 Participants will be told about the results of their tests as part of the routine management
 of their abnormal Pap results. Women participating at the University of Arizona will receive
 $25 for the time they spend in the study. Benefits that patients receive from being part of
 this study include helping researchers to discover new ways to prevent cervical cancer.
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.
-  INCLUSION CRITERIA:

 Women age 21 and older

 Non-pregnant, non-hysterectomized

 EXCLUSION CRITERIA:

 Pregnant women and women under the age of 21 will not be included in this study.