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NCT00342511 · ClinicalTrials.gov registry record
Pilots of Self-Collection for HPV DNA Detection
A clinical trial of Hpv, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 300
- Enrollment target
- 2
- Study locations
NCT00342511 is a study of Hpv that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 300 participants, below the 2,229-participant average among 24 other Hpv trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00342511, a study of Hpv, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
- 2
- Study locations
Study 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. 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 tempora
Conditions Studied
Study Locations (2)
Arizona
- University of Arizona - Tucson
Ohio
- Cleveland Clinical Health System - East Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2006-01-09 |
| Est. Completion | 2011-12-13 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00342511
The ClinicalTrials.gov registry entry for NCT00342511 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,229-participant average among 24 other Hpv trials with a reported enrollment target (87% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hpv appearing as the primary indexed condition, and to 0 interventions.
NCT00342511 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Ohio.
Frequently Asked Questions
What is clinical trial NCT00342511 about?
NCT00342511 is a clinical study titled "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 i...
What is the current status of trial NCT00342511?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2006-01-09. Estimated completion is 2011-12-13.
What conditions does trial NCT00342511 study?
This clinical trial studies the following conditions: Hpv.
Who is sponsoring clinical trial NCT00342511?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00342511 being conducted?
This trial has 2 study locations across Arizona, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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