Modeling Study to Predict Progression of Anal Cancer Pre-cursor Lesions in HIV
Predictive Modeling of Anal Dysplasia Progression in HIV
1 other identifier
observational
165
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 16, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedOctober 18, 2012
October 1, 2012
5.2 years
October 16, 2012
October 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
histological diagnosis of high-grade squamous intra-epithelial lesion confirmed by anal biopsy
12 months, 24 months, 36 months
Secondary Outcomes (1)
Regression of lesions defined by normal appearance on anoscopy and normal histology on anal biopsy following previous diagnosis of squamous intraepithelial lesion.
12 months, 24 months, 36 months
Eligibility Criteria
HIV primary care clinic
You may qualify if:
- HIV-infected
- Age \> 18 years old
- Abnormal anal screening cytology
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cincinnati VA Medical Center
Cincinnati, Ohio, 45225, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Related Links
Biospecimen
Anal cytology Anal biopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime C Robertson, MD
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 16, 2012
First Posted
October 18, 2012
Study Start
January 1, 2009
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
October 18, 2012
Record last verified: 2012-10