Pilots of Self-Collection for HPV DNA Detection
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2006 |
End Date: | December 2011 |
Pilots of Self-Collection Devices 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.
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.
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.
We found this trial at
2
sites
University of Arizona The University of Arizona is a premier, public research university. Established in...
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