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Spots Global Cancer Trial Database for Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

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Trial Identification

Brief Title: Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

Official Title: Screening HIV-Infected Women for Anal Cancer Precursors

Study ID: NCT01946139

Study Description

Brief Summary: This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the sensitivity and specificity of HPV testing using different methods of detection, including HPV Hybrid Capture 2 (HC2), HPV messenger ribonucleic acid (mRNA) assays (APTIMA) and OncoHealth HPV E6/E7 oncoprotein assay and whether they improve the screening performance of routine anal cytology for the detection of anal high-grade squamous intraepithelial lesions (HSIL) when measured against the gold standard, biopsy-proven HSIL. II. To determine the prevalence and risk factors for prevalent HSIL in HIV-infected women. III. To determine incidence and risk factors associated with anal HSIL and HPV over 2 years among HIV infected women undergoing semi-annual anal evaluations. EXPLORATORY OBJECTIVES: I. To evaluate the acceptability of anal cancer screening among HIV-infected women. II. To collect data on quality of life and health care costs (including non-direct health care costs and time costs) for an economic evaluation of the cost-effectiveness of anal cancer screening strategies in HIV-positive women. OUTLINE: Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 12 and 24 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles, California, United States

Ucsf Ancre, San Francisco, California, United States

John H. Stroger Hospital of Cook County, Chicago, Illinois, United States

Boston University Cancer Research Center, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Montefiore Medical Center, Bronx, New York, United States

Weill-Cornell Medical College, New York, New York, United States

Laser Surgery Care Center, New York, New York, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States

Baylor College of Medicine, Houston, Texas, United States

University of Puerto Rico Comprehensive Cancer Center, San Juan, , Puerto Rico

Contact Details

Name: Elizabeth Chiao

Affiliation: AIDS Associated Malignancies Clinical Trials Consortium

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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