HPVNCT00342511
Pilots of Self-Collection for HPV DNA Detection
An observational study of HPV, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jan 2006to 13 Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women age 21 and older
- Non-pregnant, non-hysterectomized
Who cannot join
- Pregnant women and women under the age of 21 will not be included in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinical Health System
East Cleveland, Ohio
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- HPV
- Keywords
- Pap, Hybrid Capture 2, HSIL, Colposcopy, CIN, Specimen Collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start9 Jan 2006
- Study completion13 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342511
- Sponsor's protocol ID
- 999906075
- Other IDs
- 06-C-N075
- Status last verified
- 13 Dec 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Taylor LA, Sorensen SV, Ray NF, Halpern MT, Harper DM. Cost-effectiveness of the conventional papanicolaou test with a new adjunct to cytological screening for squamous cell carcinoma of the uterine cervix and its precursors. Arch Fam Med. 2000 Aug;9(8):713-21. doi: 10.1001/archfami.9.8.713.
PubMed 10927709Cramer DW. The role of cervical cytology in the declining morbidity and mortality of cervical cancer. Cancer. 1974 Dec;34(6):2018-27. doi: 10.1002/1097-0142(197412)34:63.0.co;2-b. No abstract available.
PubMed 4434331Fletcher A, Metaxas N, Grubb C, Chamberlain J. Four and a half year follow up of women with dyskaryotic cervical smears. BMJ. 1990 Sep 29;301(6753):641-4. doi: 10.1136/bmj.301.6753.641.
PubMed 2224218
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilots of Self-Collection Devices for HPV DNA Detection
- ClinicalTrials.gov ID
- NCT00342511
- Acronym / sponsor ID
- 999906075
- Conditions
- HPV
- Keywords
- Pap, Hybrid Capture 2, HSIL, Colposcopy, CIN, Specimen Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Jan 2006
- Study completion
- 13 Dec 2011
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women age 21 and older
- Non-pregnant, non-hysterectomized
Key exclusion criteria (1 listed)
- Pregnant women and women under the age of 21 will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10927709Taylor LA, Sorensen SV, Ray NF, Halpern MT, Harper DM. Cost-effectiveness of the conventional papanicolaou test with a new adjunct to cytological screening for squamous cell carcinoma of the uterine cervix and its precursors. Arch Fam Med. 2000 Aug;9(8):713-21. doi: 10.1001/archfami.9.8.713.
- Background: PubMed 4434331Cramer DW. The role of cervical cytology in the declining morbidity and mortality of cervical cancer. Cancer. 1974 Dec;34(6):2018-27. doi: 10.1002/1097-0142(197412)34:63.0.co;2-b. No abstract available.
- Background: PubMed 2224218Fletcher A, Metaxas N, Grubb C, Chamberlain J. Four and a half year follow up of women with dyskaryotic cervical smears. BMJ. 1990 Sep 29;301(6753):641-4. doi: 10.1136/bmj.301.6753.641.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342511, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.