Brief Summary
This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.
Brief Title
Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the sensitivity and specificity of HPV testing using different methods of detection, including HPV Hybrid Capture 2 (HC2), HPV messenger ribonucleic acid (mRNA) assays (APTIMA) and OncoHealth HPV E6/E7 oncoprotein assay and whether they improve the screening performance of routine anal cytology for the detection of anal high-grade squamous intraepithelial lesions (HSIL) when measured against the gold standard, biopsy-proven HSIL.
II. To determine the prevalence and risk factors for prevalent HSIL in HIV-infected women.
III. To determine incidence and risk factors associated with anal HSIL and HPV over 2 years among HIV infected women undergoing semi-annual anal evaluations.
EXPLORATORY OBJECTIVES:
I. To evaluate the acceptability of anal cancer screening among HIV-infected women.
II. To collect data on quality of life and health care costs (including non-direct health care costs and time costs) for an economic evaluation of the cost-effectiveness of anal cancer screening strategies in HIV-positive women.
OUTLINE:
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 12 and 24 months.
I. To determine the sensitivity and specificity of HPV testing using different methods of detection, including HPV Hybrid Capture 2 (HC2), HPV messenger ribonucleic acid (mRNA) assays (APTIMA) and OncoHealth HPV E6/E7 oncoprotein assay and whether they improve the screening performance of routine anal cytology for the detection of anal high-grade squamous intraepithelial lesions (HSIL) when measured against the gold standard, biopsy-proven HSIL.
II. To determine the prevalence and risk factors for prevalent HSIL in HIV-infected women.
III. To determine incidence and risk factors associated with anal HSIL and HPV over 2 years among HIV infected women undergoing semi-annual anal evaluations.
EXPLORATORY OBJECTIVES:
I. To evaluate the acceptability of anal cancer screening among HIV-infected women.
II. To collect data on quality of life and health care costs (including non-direct health care costs and time costs) for an economic evaluation of the cost-effectiveness of anal cancer screening strategies in HIV-positive women.
OUTLINE:
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 12 and 24 months.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Anal Cancer
HIV Infection
Human Papilloma Virus Infection
Eligibility Criteria
Inclusion Criteria:
* HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay \[ELISA\], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
* Karnofsky performance status \> 70%
* Absolute neutrophil count \>= 750 cells/mm\^3 within 120 days of study entry
* Platelet count \>= 75,000 cells/mm\^3 within 120 days of study entry
Exclusion Criteria:
* Current or history of anal or perianal carcinoma
* History of anal HSIL cytology or histology
* Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal
* For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study
* Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
* Ongoing use of anticoagulant therapy other than aspirin, clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDS)
* Inability to provide informed consent
* Treatment of anal and/or perianal HPV associated disease (i.e., condyloma or low-grade anal intraepithelial neoplasia \[AIN\]) within 4 months of study entry
* HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay \[ELISA\], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
* Karnofsky performance status \> 70%
* Absolute neutrophil count \>= 750 cells/mm\^3 within 120 days of study entry
* Platelet count \>= 75,000 cells/mm\^3 within 120 days of study entry
Exclusion Criteria:
* Current or history of anal or perianal carcinoma
* History of anal HSIL cytology or histology
* Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal
* For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study
* Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
* Ongoing use of anticoagulant therapy other than aspirin, clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDS)
* Inability to provide informed consent
* Treatment of anal and/or perianal HPV associated disease (i.e., condyloma or low-grade anal intraepithelial neoplasia \[AIN\]) within 4 months of study entry
Inclusion Criteria
Inclusion Criteria:
* HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay \[ELISA\], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
* Karnofsky performance status \> 70%
* Absolute neutrophil count \>= 750 cells/mm\^3 within 120 days of study entry
* Platelet count \>= 75,000 cells/mm\^3 within 120 days of study entry
* HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay \[ELISA\], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
* Karnofsky performance status \> 70%
* Absolute neutrophil count \>= 750 cells/mm\^3 within 120 days of study entry
* Platelet count \>= 75,000 cells/mm\^3 within 120 days of study entry
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01946139
Org Class
Network
Org Full Name
AIDS Malignancy Consortium
Org Study Id
AMC-084
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Screening HIV-Infected Women for Anal Cancer Precursors
Primary Outcomes
Outcome Description
Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay
Outcome Measure
Specificity of Each Other Methods of HSIL Detection for APTIMA Assay
Outcome Time Frame
at baseline
Outcome Description
The prevalence of HSIL will be estimated as the proportion of women who are HRA positive for HSIL at entry and its 95% confidence interval. Logistic regression analysis will be used to evaluate the association of potential risk factors with diagnosis of HSIL.
Outcome Measure
Prevalence of HSIL
Outcome Time Frame
at baseline
Outcome Description
Among patients whose high resolution anoscopy (HRA) results were positive for HSIL and had APTIMA assays at baseline, the number whose APTIMA assay results were positive.
Outcome Measure
Sensitivity of Each of the Methods of APTIMA Assay at Baseline
Outcome Time Frame
at baseline
Outcome Description
The Poisson rate and its 95% confidence interval will be estimated from the number of HSIL cases detected divided by the cumulative years of follow-up across these cases.
Outcome Measure
Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry
Outcome Time Frame
Up to 2 years
Secondary Ids
Secondary Id
NCI-2013-01637
Secondary Id
AMC-084
Secondary Id
AMC-084
Secondary Id
R01CA163103
Secondary Id
U01CA121947
Secondary Outcomes
Outcome Description
Anal cancer screening is typically done using a high resolution anoscopy, a device which allows visualization of the anus. To determine if participants found anal screening acceptable, they were asked if they were at east with having a high resolution anoscopy. The results indicated the number of participants who felt at ease with having a high resolution anoscopy
Outcome Time Frame
at baseline
Outcome Measure
Acceptability of Anal Cancer Screening
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rebecca Levine
Investigator Email
relevine@montefiore.org
Investigator Phone
718-405-8236
Categories Mesh Debug
Kaposi Sarcoma & AIDS-Related Cancers --- HIV INFECTIONS
HIV/AIDS --- HIV INFECTIONS
Infectious Disease --- HIV INFECTIONS
Gastrointestinal (GI) Cancers --- COLORECTAL NEOPLASMS
Gastrointestinal (GI) Cancers --- INTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
Blood Disorders --- BLOOD-BORNE INFECTIONS
HIV/AIDS --- BLOOD-BORNE INFECTIONS
Infectious Disease --- BLOOD-BORNE INFECTIONS
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES, VIRAL
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES, VIRAL
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- LENTIVIRUS INFECTIONS
Infectious Disease --- RETROVIRIDAE INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
Infectious Disease --- IMMUNOLOGIC DEFICIENCY SYNDROMES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
ANUS NEOPLASMS
HIV INFECTIONS
PAPILLOMAVIRUS INFECTIONS
RECTAL NEOPLASMS
COLORECTAL NEOPLASMS
INTESTINAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
DIGESTIVE SYSTEM DISEASES
GASTROINTESTINAL DISEASES
INTESTINAL DISEASES
ANUS DISEASES
RECTAL DISEASES
BLOOD-BORNE INFECTIONS
COMMUNICABLE DISEASES
INFECTIONS
SEXUALLY TRANSMITTED DISEASES, VIRAL
SEXUALLY TRANSMITTED DISEASES
LENTIVIRUS INFECTIONS
RETROVIRIDAE INFECTIONS
RNA VIRUS INFECTIONS
VIRUS DISEASES
GENITAL DISEASES
UROGENITAL DISEASES
IMMUNOLOGIC DEFICIENCY SYNDROMES
IMMUNE SYSTEM DISEASES
DNA VIRUS INFECTIONS
TUMOR VIRUS INFECTIONS
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS