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

Primary Purpose

Anal Carcinoma, HIV Infection, Human Papillomavirus Infection

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytology Specimen Collection Procedure
Laboratory Biomarker Analysis
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Los Angeles Gay and Lesbian Center
  • UCLA / Jonsson Comprehensive Cancer Center
  • Desert AIDS Project

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (anal cytology collection)

Arm Description

Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.

Outcomes

Primary Outcome Measures

Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
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

Ability of APTIMA-HPV to predict risk for HG-AIN
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.
Ability of Hybrid-capture 2 to predict risk for HG-AIN
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.
Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.
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.

Full Information

First Posted
May 23, 2016
Last Updated
July 6, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02816879
Brief Title
Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men
Official Title
Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Carcinoma, HIV Infection, Human Papillomavirus Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening (anal cytology collection)
Arm Type
Experimental
Arm Description
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
Intervention Type
Procedure
Intervention Name(s)
Cytology Specimen Collection Procedure
Other Intervention Name(s)
Cytologic Sampling
Intervention Description
Undergo anal cytology collection
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
Description
Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) & histology.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Ability of APTIMA-HPV to predict risk for HG-AIN
Description
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.
Time Frame
Baseline
Title
Ability of Hybrid-capture 2 to predict risk for HG-AIN
Description
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.
Time Frame
Baseline
Title
Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy Wiley
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Gay and Lesbian Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Desert AIDS Project
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States

12. IPD Sharing Statement

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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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