Recruiting

Observational StudyModeling Study to Predict Progression of Anal Cancer Pre-cursor Lesions in HIV

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT01709448

Conditions

Neoplasms, Squamous Cell

Papillomavirus Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to determine whether a model can be created to predict the progression of early anal cancer precursor lesions in HIV using potential predictors such as: HIV treatment history, smoking history, sexual history, human papillomavirus viral load, human papillomavirus protein expression, and cell markers associated with progression of HPV-related lesions.

Conditions

Neoplasms, Squamous Cell

Papillomavirus Infections

Study ID

NCT01709448

Start date

Jan, 2009

Status verified date

Oct, 2012

Completion date

Mar, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

HIV-infected
Age > 18 years old
Abnormal anal screening cytology

Exclusion Criteria:

Inability to sign informed consent
Life-threatening illness or other contraindication for high-resolution anoscopy
anal intraepithelial neoplasia not confirmed by anal biopsy
history of anal carcinoma
history of HPV vaccination

Study Design

Enrollment

165 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

histological diagnosis of high-grade squamous intra-epithelial lesion confirmed by anal biopsy [ Time Frame: 12 months, 24 months, 36 months ]

Central Contacts and Locations

Central contacts

Jaime C Robertson, MD

(513) 584-5827 roberj5@ucmail.uc.edu

Eva Moore, RN

(513) 584-4819 mooreev@ucmail.uc.edu

Locations

Cincinnati VA Medical Center

Recruiting

Cincinnati, Ohio, United States, 45225

Contacts

George Smulian, MD

513-861-3100 smuliang@fuse.net

Diana Moore, ARNP

(513) 475-6599 Diana.Moore2@va.gov

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Jaime C Robertson, MD

513-584-5827 roberj5@ucmail.uc.edu

Eva Moore, RN

(513) 584-4819 mooreev@ucmail.uc.edu

Principal Investigator:

Jaime C Robertson, MD

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Oct 18, 2012

Last verified

Oct, 2012

Keywords

Neoplasms, Squamous Cell
Papillomavirus Infections
HIV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2012-10-18.