Pilots of Self-Collection for HPV DNA Detection

NCT00342511 | Completed

• 2 other identifiers: 99990607506-C-N075
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

HPV

Keywords

Pap; Hybrid Capture 2; HSIL; Colposcopy; CIN; Specimen Collection

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 21 and older
• Non-pregnant, non-hysterectomized

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Cleveland Clinical Health System

East Cleveland, Ohio, United States

Location

Related Publications (3)

• 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.

  PMID: 10927709 BACKGROUND

• Cramer 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.

  PMID: 4434331 BACKGROUND

• Fletcher 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.

  PMID: 2224218 BACKGROUND

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: January 9, 2006
• Study Completion: December 13, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-12-13

Locations

US (2)