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Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men

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ClinicalTrials.gov Identifier: NCT02816879
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : September 28, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.

Condition or disease Intervention/treatment Phase
Anal Carcinoma HIV Infection Human Papillomavirus Infection Procedure: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate the sensitivity & specificity, predictive positive value (PPV), & predictive negative value (PNV) (test characteristics) & cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), & protein (quality measures) from nylon-flocked (NF)- & Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) & human papillomavirus (HPV)-infections, using randomized-controlled study design.

II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with & without cytology, to predict HG-AIN.

III. Evaluate the cost-effectiveness & relative cost of single- & multiple-test anal cancer screening algorithms.

OUTLINE:

Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and polymerase chain reaction (PCR).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM
Actual Study Start Date : August 1, 2013
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Screening (anal cytology collection)
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
Procedure: Cytology Specimen Collection Procedure
Undergo anal cytology collection
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome [ Time Frame: Baseline ]
    Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) & histology.


Secondary Outcome Measures :
  1. Ability of APTIMA-HPV to predict risk for HG-AIN [ Time Frame: Baseline ]
    Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV & HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) & the findings for APTIMA-HPV & HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- & Dacron protocols for HPV genotypes will be summarized in tabular & graphical form.

  2. Ability of Hybrid-capture 2 to predict risk for HG-AIN [ Time Frame: Baseline ]
    Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV & HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) & the findings for APTIMA-HPV & HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- & Dacron protocols for HPV genotypes will be summarized in tabular & graphical form.

  3. Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer. [ Time Frame: Up to 3 years ]
    The cost-effectiveness analyses calculate incremental cost-effectiveness ratios (ICERs) comparing two intervention groups/strategies to the current standard of care, Dacron cytology alone. The ICER is the ratio of the difference in the total costs per patient between groups (numerator) versus the difference in quality-adjusted life-years (QALY) between groups (denominator). Specifically, for these analyses, ICERs are separately estimated for best single & best combination screening algorithm relative to usual care (Dacron-cytology). The analysis focuses on life-time costs.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects are being enrolled

Information from the National Library of Medicine

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): NCT02816879


Locations
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United States, California
Los Angeles Gay and Lesbian Center
Los Angeles, California, United States, 90028
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Desert AIDS Project
Palm Springs, California, United States, 92262
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Dorothy Wiley UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02816879    
Other Study ID Numbers: RCA169508A
NCI-2014-01292 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JCCCID370 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
RCA169508A ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
R01CA169508 ( U.S. NIH Grant/Contract )
13-000997 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Papillomavirus Infections
Anus Neoplasms
Disease Attributes
Pathologic Processes
Virus Diseases
DNA Virus Infections
Tumor Virus 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