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

This study is currently recruiting participants.
Verified October 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborators:
University of Cincinnati
Cincinnati VA Medical Center
Information provided by (Responsible Party):
Jaime Robertson, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01709448
First received: October 16, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition
Neoplasms, Squamous Cell
Papillomavirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Modeling of Anal Dysplasia Progression in HIV

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • histological diagnosis of high-grade squamous intra-epithelial lesion confirmed by anal biopsy [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Anal cytology Anal biopsies


Estimated Enrollment: 165
Study Start Date: January 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709448

Contacts
Contact: Jaime C Robertson, MD (513) 584-5827 roberj5@ucmail.uc.edu
Contact: Eva Moore, RN (513) 584-4819 mooreev@ucmail.uc.edu

Locations
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         
Sponsors and Collaborators
University of Cincinnati
Cincinnati VA Medical Center
Investigators
Principal Investigator: Jaime C Robertson, MD University of Cincinnati
  More Information

Additional Information:
No publications provided

Responsible Party: Jaime Robertson, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01709448     History of Changes
Other Study ID Numbers: 1K23AI080202-01, 1K23AI080202-01
Study First Received: October 16, 2012
Last Updated: October 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Neoplasms, Squamous Cell
Papillomavirus Infections
HIV

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Squamous Cell
Papillomavirus Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on April 20, 2014