ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02816879
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
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
Study Start Date : July 9, 2013
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2019

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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
United States, California
Los Angeles Gay and Lesbian Center Recruiting
Los Angeles, California, United States, 90028
Contact: Robert Bolan    323-993-7577    bbolan@lagaycenter.org   
Principal Investigator: Robert Bolan         
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Dorothy J. Wiley    310-825-0540    dwiley@ucla.edu   
Principal Investigator: Dorothy J. Wiley         
Desert AIDS Project Recruiting
Palm Springs, California, United States, 92262
Contact: Matt G. Moran       mmoran@desertaidsproject.org   
Principal Investigator: Matt G. Moran         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Dorothy Wiley UCLA / Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02816879     History of Changes
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 )
P30CA016042 ( U.S. NIH Grant/Contract )
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 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Papillomavirus Infections
Infection
Communicable Diseases
HIV Infections
Anus Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System 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