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

NCT ID: NCT01709448

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms, Squamous Cell Papillomavirus Infections

Keywords

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Neoplasms, Squamous Cell Papillomavirus Infections HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role collaborator

Cincinnati VA Medical Center

OTHER_GOV

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Jaime Robertson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime C Robertson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jaime C Robertson, MD

Role: CONTACT

Phone: (513) 584-5827

Email: [email protected]

Eva Moore, RN

Role: CONTACT

Phone: (513) 584-4819

Email: [email protected]

Facility Contacts

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George Smulian, MD

Role: primary

Diana Moore, ARNP

Role: backup

Jaime C Robertson, MD

Role: primary

Eva Moore, RN

Role: backup

Related Links

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http://intmed.uc.edu/divisions/infectious_diseases/

University of Cincinnati - Division of Infectious Diseases

http://www.cincinnati.va.gov/

Cincinnati VA Medical Center

Other Identifiers

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1K23AI080202-01

Identifier Type: NIH

Identifier Source: secondary_id

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1K23AI080202-01

Identifier Type: NIH

Identifier Source: org_study_id

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