Modeling Study to Predict Progression of Anal Cancer Pre-cursor Lesions in HIV
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ClinicalTrials.gov Identifier: NCT01709448 |
Recruitment Status
: Unknown
Verified October 2012 by Jaime Robertson, University of Cincinnati.
Recruitment status was: Recruiting
First Posted
: October 18, 2012
Last Update Posted
: October 18, 2012
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Condition or disease |
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Neoplasms, Squamous Cell Papillomavirus Infections |
Persons living with HIV-infection are at greatly increased risk for anal carcinoma and anal intraepithelial neoplasia (AIN). Despite the overall improvement in HIV outcomes, the incidence of anal carcinoma has not decreased with the advent of highly active antiretroviral ther-apy. Further, there is substantial morbidity and mortality associated with anal carcinoma in HIV-infected individuals. For these reasons, it is critically important to develop effective screening and treatment strategies in this population. Anal carcinoma is similar to cervical carcinoma in that they are both associated with infection with human papillomavirus (HPV) and share similar cytologic features of dysplasia. Anal cytology screening is ultimately expected to reduce the incidence of anal carcinoma similar to that seen with cervical cancer after the introduction of cervical Pap screening. Given the high frequency of abnormal cytology in patients with HIV and the need to confirm results by high-resolution anoscopy, however, the implementation of screening programs requires a substantial commitment of clinical resources. The workload and costs involved in following up on abnormal cytology reduce the cost-effectiveness of screening and pose a significant barrier to its widespread integration into routine HIV care. A model for predicting which patients are at greatest risk for progressive of anal dysplasia is needed in order to decrease the need for excessive confirmatory procedures in this population. Without such a model, anal carcinoma screening may remain cost prohibitive for many HIV clinics.
The objective of this study is to develop a predictive model to identify patients who are at greatest risk for progression of anal intraepithelial neoplastic changes. The central hypotheses are: 1) that progression of early HPV-related anal dysplasia is associated with environmental, virological, and host molecular factors and 2) that it is possible to develop a predictive statistical model with a high sensitivity and specificity for predicting disease progression. These hypotheses have been formulated on the basis of strong evidence from studies of HPV-related cervical dysplasia that smoking, HPV E2 expression, HPV E6/E7 protein expression, high-risk HPV type, HPV viral load, p16 expression, p53 expression and Ki67 expression are associated with progressive cervical dysplasia. The rationale for the proposed research is that development of a predictive model will allow clinicians to design more cost-effective screening and follow-up strategies which focus resources on intensively testing only those patients with a significant risk for progression. Further, the models developed will allow clinicians to identify a population of patients who may benefit from early treatment interventions. Finally, information learned from this research may provide information applicable to other HPV-related cancers.
Study Type : | Observational |
Estimated Enrollment : | 165 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Predictive Modeling of Anal Dysplasia Progression in HIV |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | March 2014 |
Estimated Study Completion Date : | March 2014 |

- histological diagnosis of high-grade squamous intra-epithelial lesion confirmed by anal biopsy [ Time Frame: 12 months, 24 months, 36 months ]
- Regression of lesions defined by normal appearance on anoscopy and normal histology on anal biopsy following previous diagnosis of squamous intraepithelial lesion. [ Time Frame: 12 months, 24 months, 36 months ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709448
Contact: Jaime C Robertson, MD | (513) 584-5827 | roberj5@ucmail.uc.edu | |
Contact: Eva Moore, RN | (513) 584-4819 | mooreev@ucmail.uc.edu |
United States, Ohio | |
Cincinnati VA Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45225 | |
Contact: George Smulian, MD 513-861-3100 ext 4425 smuliang@fuse.net | |
Contact: Diana Moore, ARNP (513) 475-6599 Diana.Moore2@va.gov | |
Sub-Investigator: George Smulian, MD | |
Sub-Investigator: Stephen Kralovic, MD | |
Sub-Investigator: Diana Moore, ARNP | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
Contact: Jaime C Robertson, MD 513-584-5827 roberj5@ucmail.uc.edu | |
Contact: Eva Moore, RN (513) 584-4819 mooreev@ucmail.uc.edu | |
Principal Investigator: Jaime C Robertson, MD |
Principal Investigator: | Jaime C Robertson, MD | University of Cincinnati |
Additional Information:
Responsible Party: | Jaime Robertson, Assistant Professor, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT01709448 History of Changes |
Other Study ID Numbers: |
1K23AI080202-01 ( U.S. NIH Grant/Contract ) |
First Posted: | October 18, 2012 Key Record Dates |
Last Update Posted: | October 18, 2012 |
Last Verified: | October 2012 |
Keywords provided by Jaime Robertson, University of Cincinnati:
Neoplasms, Squamous Cell Papillomavirus Infections HIV |
Additional relevant MeSH terms:
Papillomavirus Infections Neoplasms, Squamous Cell DNA Virus Infections Virus Diseases |
Tumor Virus Infections Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |