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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA215403 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The University of Texas Health Science Center, Houston | OTHER |
| M.D. Anderson Cancer Center | OTHER |
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The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM) and transgender persons. This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.
This is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based DNA screening of anal canal exfoliated cells among Milwaukee HIV+ and HIV- men who have sex with men (MSM) and transgender persons aged ≥25 years. At study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. Then, persons will receive high-resolution anoscopy (HRA)-directed biopsy to assess precancerous lesions by study arm. We hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. The proposed research could indicate that annual HPV DNA screening and subsequent HRA are acceptable to MSM and transgender persons; thus, we will determine how high-risk persons are identified for HRA in light of limited HRA resources. The duration of each participant's activities is expected to be 12 months. The study is expected have participant activity from 2019 to 2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based human papillomavirus (HPV) DNA screening | Experimental | Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. |
|
| Clinic-based human papillomavirus (HPV) DNA screening | Active Comparator | Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based human papillomavirus (HPV) DNA screening | Behavioral | Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Annual Anal HPV DNA Screening | Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening | Baseline |
| Compliance With Annual Anal HPV DNA Screening | Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Annual Screening Based on HIV Status | The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year. | 12 months 12 months |
| Compliance With Annual Screening Based on Race/Ethnicity |
| Measure | Description | Time Frame |
|---|---|---|
| Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL). | 12 months |
| Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. |
Inclusion Criteria:
Exclusion Criteria:
cis males and transgender persons who have sex with men
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| Name | Affiliation | Role |
|---|---|---|
| Alan G Nyitray, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870947 | Derived | Nitkowski J, Giuliano AR, Ridolfi T, Chiao E, Fernandez ME, Schick V, Swartz MD, Smith JS, Nyitray AG. Acceptability of Anal Human Papillomavirus Home Self-Sampling and Clinician Sampling Among Sexual and Gender Minority Individuals in Milwaukee, Wisconsin: The Prevent Anal Cancer Self-Swab Study. LGBT Health. 2024 Jan;11(1):47-56. doi: 10.1089/lgbt.2023.0012. Epub 2023 Oct 24. | |
| 34187833 | Derived | Nyitray AG, Schick V, Swartz MD, Giuliano AR, Fernandez ME, Deshmukh AA, Ridolfi TJ, Ajala C, Brzezinski B, Sandoval M, Nedjai B, Smith JS, Chiao EY. Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening. BMJ Open. 2021 Jun 29;11(6):e051118. doi: 10.1136/bmjopen-2021-051118. |
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Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
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Data will become available three years after study completion and be available for five years.
Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Home-based Human Papillomavirus (HPV) DNA Screening | Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. |
| FG001 | Clinic-based Human Papillomavirus (HPV) DNA Screening | Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
|
| ||||||||||||||||||
| 12 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home-based Human Papillomavirus (HPV) DNA Screening | Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The unit of analysis is the individual. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compliance With Annual Anal HPV DNA Screening | Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening | One-hundred and seven of 120 in the Home-Based arm and 89 of 120 in the Clinic-based arm complied at Baseline by providing specimens for annual anal HPV DNA screening (Primary Outcome Measure 1). | Posted | Count of Participants | Participants | Baseline |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home-based Human Papillomavirus (HPV) DNA Screening | Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Nyitray, PhD | Medical College of Wisconsin | 414-955-7701 | anyitray@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2023 | Jun 6, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2022 | Mar 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Clinic-based human papillomavirus (HPV) DNA screening | Behavioral | Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. |
|
The number of participants complying with annual screening based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White. Compliance is defined as screening at baseline and one year. |
| 12 months |
| Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | The number of participants attending high-resolution anoscopy based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White. | 12 months |
| Number of Participants Attending High-resolution Anoscopy Based on HIV Status | The number of participants attending high-resolution anoscopy based on positive or negative HIV status. | 12 months |
| Attendance at High-resolution Anoscopy | Number of participants who attend high-resolution anoscopy (HRA) | 12 months |
Mean of host/viral methylation score among participants stratified by high-grade squamous intraepithelial lesions. The Score 5 (S5) methylation score is an arithmetic continuous risk score with a minimum value of 0 and no maximum value. Higher methylation scores indicate higher risk for disease. While a theoretical maximum for a methylation score does not exist, one published maximum value for anal cancer is approximately 100. In this publication (Lorincz et al., Methylation of HPV and a tumor suppressor gene reveals anal cancer and precursor lesions, DOI: 10.18632/oncotarget.17984), a cut-off of 7.5 for methylation score identified all anal cancers and HSIL. |
| 12 months |
| NOT COMPLETED |
|
|
| Clinic-based Human Papillomavirus (HPV) DNA Screening |
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clinic-based Human Papillomavirus (HPV) DNA Screening |
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. |
|
|
| Primary | Compliance With Annual Anal HPV DNA Screening | Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening | Seventy-eight of 120 in the Home-Based arm and 63 of 120 in the Clinic-based arm complied at 12-months by providing specimens for annual anal HPV DNA screening (Primary Outcome Measure 2). | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Compliance With Annual Screening Based on HIV Status | The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year. | The row totals for each column equal the overall number of participants analyzed (the arm totals/column totals). | Posted | Count of Participants | Participants | 12 months 12 months |
|
|
|
| Secondary | Compliance With Annual Screening Based on Race/Ethnicity | The number of participants complying with annual screening based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White. Compliance is defined as screening at baseline and one year. | The row totals for each column, equal the overall number of participants analyzed (the arm totals/column totals). | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | The number of participants attending high-resolution anoscopy based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White. | The row totals for each column equal the overall number of participants analyzed (the arm totals/column totals). | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | The number of participants attending high-resolution anoscopy based on positive or negative HIV status. | The row totals for each column, equal the overall number of participants analyzed (the arm totals/column totals). | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Attendance at High-resolution Anoscopy | Number of participants who attend high-resolution anoscopy (HRA) | Sixty-two of 120 home-based participants and 71 of 120 clinic-based participants attended HRA. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL). | Only participants who provided a swab at both baseline and 12 months are assessed for high-risk HPV DNA persistence. Only those assessed for high-risk persistence are included the analysis of the number of high-grade squamous intraepithelial lesions. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | Mean of host/viral methylation score among participants stratified by high-grade squamous intraepithelial lesions. The Score 5 (S5) methylation score is an arithmetic continuous risk score with a minimum value of 0 and no maximum value. Higher methylation scores indicate higher risk for disease. While a theoretical maximum for a methylation score does not exist, one published maximum value for anal cancer is approximately 100. In this publication (Lorincz et al., Methylation of HPV and a tumor suppressor gene reveals anal cancer and precursor lesions, DOI: 10.18632/oncotarget.17984), a cut-off of 7.5 for methylation score identified all anal cancers and HSIL. | Participants who have both high-resolution anoscopy histology result & methylation score (n=133 of 240 total participants) are analyzed here, whether or not they were analyzed for high-risk HPV persistence. Participants who do not have both high-resolution anoscopy biopsy histology result & methylation score = 107 of 240 total participants. | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
| EG001 | Clinic-based Human Papillomavirus (HPV) DNA Screening | Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. | 0 | 120 | 0 | 120 | 0 | 120 |
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| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| Did not provide specimens |
|
| HIV-negative |
|
|
| Did not provide specimens |
|
| Black/Non-Hispanic |
|
|
| Hispanic |
|
|
| Asian (Not Hispanic or Latino) |
|
|
| American Indian/Alaskan Native (Not Hispanic or Latino) |
|
|
| I don't know/Not Reported |
|
|
| Other |
|
|
| Did not attend HRA |
|
| Black/Non-Hispanic |
|
|
| Hispanic |
|
|
| Asian (Not Hispanic or Latino) |
|
|
| American Indian/Alaskan Native (Not Hispanic or Latino) |
|
|
| Other (Not Hispanic or Latino) |
|
|
| I don't know/Not reported |
|
|
| Did not attend HRA |
|
| HIV-negative |
|
|
| Assessed for persistence |
|
|
| Persistent |
|
|
| persistent ≥HSIL |
|
|
| persistent <HSIL |
|
|
| Not persistent |
|
|
| not persistent ≥HSIL |
|
|
| not persistent < HSIL |
|
|
| Did not attend HRA (preventing HSIL assessment) |
|
|
| <HSIL |
|
|