NeoplasmsNCT06628570
Screening Strategies Among High-risk Populations for Anal Cancer
A study testing HRA + Biopsy, Anal Cytology and Genotyping of anal hrHPV infection in people with Neoplasms and HPV-Related Anal Squamous Cell Carcinoma, run by Lisa Flowers at 4 sites in United States.
Trial summary
The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, HPV-Related Anal Squamous Cell Carcinoma
- What is being tested?
- HRA + Biopsy, Anal Cytology and Genotyping of anal hrHPV infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Dec 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-80 years of age
- Individuals with chronic impaired immune status
- History of lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2
Who cannot join
- Patients treated for aHSIL less than 6 months before screening
- History of anal cancer and pregnant women.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
- Recruiting
The Ponce Center
Atlanta, Georgia, 30308
Lisa Flowers, MD, 404 778 1380, lflowe2@emory.edu
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Isabella Rosa-Cunah, MD
- Recruiting
University of Miami School of Medicine at Jackson Memorial Hospital (JMH)
Miami, Florida, 33136
Isabella Rosa-Cunha, MD
About this study
The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.
Read the detailed description
Anal cancer, caused by persistent infection with high-risk human papillomavirus (hrHPV), is typically preceded by anal high-grade squamous intraepithelial lesions (aHSIL). The incidence and mortality of advanced anal cancer has been increasing in the U.S., with the greatest burden of disease and mortality in individuals with chronic impairment of the immune system. The study is important because the incidence of anal cancer is particularly high among certain groups. Findings will provide much-needed evidence for anal cancer screening strategies to reduce incidence of anal cancer and improve health outcomes. The study population includes individuals with chronic impairment of the immune system and females with a known history of high-grade lower genital tract neoplasia.
The study procedures include filling out self-reported questionnaires and collecting biosamples for study-related assays. HRA is part of the standard clinic procedure for this group of participants. Collected biosamples will be banked for future research use. In-person or remote signed consent may occur for the study.
- Being tested
- HRA + Biopsy, Anal Cytology, Genotyping of anal hrHPV infection, CINtec®PLUS
- Keywords
- Cancer, HIV, Screening
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRA + BiopsyDiagnostic test
Also called HRA and Histology
High-Resolution Anoscopy, or HRA, is a standard of care procedure for screening and detection of premalignant lesions of the anus. Using a small, thin round tube called an anoscope, the anal canal is examined with a high-resolution magnifying instrument called a colposcope. The application of a mildly acidic liquid on the anal canal facilitates the evaluation of abnormal tissue such as anal dysplasia. Biopsies for histological confirmation of disease will be taken. Biopsies' reporting will follow the terminology, criteria, and recommendations of the Lower Anogenital Squamous Terminology (LAST) project. Histology results will be reported as benign, condyloma acuminatum, AIN grades 1-3, or cancer. For the proposed project, aHSIL+ will be defined as AIN2 (p16 block-positive), AIN3, and cancer at the HRA encounter. All other cases will be classified as <aHSIL, including benign, condyloma acuminatum, and AIN1
Anal CytologyDiagnostic test
Also called Swab anal Sample
Anal cytology collection (swab samples) will be performed as part of the standard of care during this study. The collected cells, suspended in the SurePath liquid-based medium, will be placed on a slide and microscopically examined by a board-certified pathologist. The sample will then be interpreted using the Bethesda System: negative for intraepithelial lesion or malignancy (NILM), ASCUS, LSIL, ASC-H, or HSIL. Pathologists interpreting the anal cytology will be blinded from hrHPV testing and biopsy histology.
Genotyping of anal hrHPV infectionDiagnostic test
Also called hrHPV
Samples of exfoliated cells from the anal canal will be collected with Dacron swabs. To identify the infecting HPV genotype, DNA will be extracted from swab samples collected with the MagNA Pure LC DNA Isolation Kit III and an LC MagNA Pure system (Roche Diagnostics GmbH, Mannheim, Germany), followed by HPV typing using the TypeSeq assay, a laboratory prepared high-throughput next-generation sequencing assay developed by NCI will be performed as described. The assay uses three sequential PCR steps resulting in barcoded L1 amplicons sequenced and submitted to a bioinformatics pipeline for typing. This TypeSeq assay qualitatively detects and identifies 51 HPV genotypes (HPV types 3, 6, 11, 13, 16, 18, 26, 28, 30, 31, 32, 33, 34, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 67, 68, 69, 70, 71, 72, 73, 74, 76, 81, 82, 83, 84, 85, 86, 87, 89, 90, 91, 97, and 114), including 14 high-risk (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
CINtec®PLUSDiagnostic test
Also called P16/Ki-67 dual immunostaining
Samples of exfoliated cells from the anal canal will be collected with Dacron swabs. Dual immunostaining with p16/Ki-67 will be performed on the residual cytologic specimen by Roche MTM Laboratories (Heidelberg, Germany), using the CINtec®PLUS Kit according to the manufacturer's instructions. The anal cytology material will be stained with a mouse monoclonal antibody directed against human p16INKa (p16) protein (clone E6H4) and recombinant rabbit monoclonal antibody directed against human Ki-67 protein (clone 274-11AC3V1), using the BenchMark ULTRA instrument (Ventana Roche). Samples with insufficient cellularity will be excluded from the evaluation. A trained cytotechnologist will review all cases for cells staining positively with both markers. A slide will be considered positive if 1 or more squamous epithelial cell(s) stained positive for both p16 and Ki-67 and dual stain-positive cells will be semi-quantitatively assessed (0, 1, 2-5, 6-50, >50).
| Study group | Role | What they receive |
|---|---|---|
| Men with impaired immune status | Other | At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. Receives: Diagnostic Test: HRA + Biopsy; Diagnostic Test: Anal Cytology; Diagnostic Test: Genotyping of anal hrHPV infection; Diagnostic Test: CINtec®PLUS |
| Men without impaired immune status | Other | At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. Receives: Diagnostic Test: HRA + Biopsy; Diagnostic Test: Anal Cytology; Diagnostic Test: Genotyping of anal hrHPV infection; Diagnostic Test: CINtec®PLUS |
| Women with impaired immune status and and lower genital tract neoplasia (LGTN) | Other | At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. Receives: Diagnostic Test: HRA + Biopsy; Diagnostic Test: Anal Cytology; Diagnostic Test: Genotyping of anal hrHPV infection; Diagnostic Test: CINtec®PLUS |
| Women without impaired immune status and lower genital tract neoplasia (LGTN) | Other | At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. Receives: Diagnostic Test: HRA + Biopsy; Diagnostic Test: Anal Cytology; Diagnostic Test: Genotyping of anal hrHPV infection; Diagnostic Test: CINtec®PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and Sensitivity of screening markers
Sensitivity and specificity will be calculated for each of the proposed screening markers separately and a combination of two and three markers for the detection of aHSIL at baseline. The combination of the two and three markers of primary interest includes CINtec®PLUS +hrHPV, CINtec®PLUS+anal cytology, hrHPV+anal cytology, and CINtec®PLUS+hrHPV+anal cytology. The analysis will be performed for the four high-risk groups together and stratified by the four high-risk categories.
Measured: Baseline
Secondary outcomes (7)
DNA methylation markers
In these models, aHSIL status at baseline will be considered as the response, and each anal DNA methylation marker will be the predictor. Separate models will be performed for each methylation marker (ZNF582, ASCL1, ZIC1, SST, LHX8, WDR17, and ST6GALNAC5)
Measured: Baseline, 1 year, 2 years
Anal immune modulations
High-risk HPV 16 persistent patients (N=10) vs. patients with no HPV at least two consecutive times (N=10). Each of the groups will also include aHSIL+ (N=5) vs. <aLSIL (N=5).
Measured: Baseline, 1 year, 2 years
aHSIL prevalence
The prevalence of HSIL will be estimated as the proportion of participants 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.
Measured: Baseline
aHSIL clearance
Only people treated with aHSIL will be used for the clearance analysis. Clearance (HRA biopsy-proven) will be defined as no detectable aHSIL at the immediate one-year (for those with baseline aHSIL) or two-year (for those with newly diagnosed aHSIL cases at the one-year visit) follow-up visit after aHSIL treatment.
Measured: 1 year, 2 years
Inflammatory Markers (Il-1RA, IL1β, IL6, IL6sr, TNF-α, and IL-10)
Anal swab concentrations of inflammatory markers (IL1ra, IL1β, IL6, IL6sr, TNF-α, and IL-10) will be determined using multiplex assays (Meso Scale Discovery, Rockville, MD) according to the manufacturer's protocol. All samples will be run in duplicates, and mean intra- and inter-assay CVs will be calculated and expected to be <10%. These inflammatory markers have been reliably found to be elevated in inflammatory-associated diseases including anal inflammation.
Measured: Baseline, 1 year, 2 years
Inflammatory Markers (sTNFR2 and interferon (IFN)-γ)
Anal swab concentrations of inflammatory markers of inflammatory markers (sTNFR2 and interferon (IFN)-γ) will be determined using multiplex assays (Meso Scale Discovery, Rockville, MD) according to the manufacturer's protocol.
Measured: Baseline, 1 year, 2 years
Inflammatory Marker (CRP)
Anal swab concentrations of inflammatory markers (CRP) will be determined using multiplex assays (Meso Scale Discovery, Rockville, MD) according to the manufacturer's protocol. All samples will be run in duplicates, and mean intra- and inter-assay CVs will be calculated and expected to be <10%.
Measured: Baseline, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start16 Dec 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisa Flowers
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Lisa Flowers, Emory University
- Investigators
- Lisa Flowers, MD, MPH, Principal investigator, Emory UniversityCanhua Xiao, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628570
- Sponsor's protocol ID
- STUDY00006091
- Other IDs
- R01CA285198, 2025P011462
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected from study participation will be available for sharing after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Strategies Among High-risk Populations for Anal Cancer
- ClinicalTrials.gov ID
- NCT06628570
- Acronym / sponsor ID
- STUDY00006091
- Keywords
- Cancer, HIV, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lisa FlowersUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.
Detailed description
Anal cancer, caused by persistent infection with high-risk human papillomavirus (hrHPV), is typically preceded by anal high-grade squamous intraepithelial lesions (aHSIL). The incidence and mortality of advanced anal cancer has been increasing in the U.S., with the greatest burden of disease and mortality in individuals with chronic impairment of the immune system. The study is important because the incidence of anal cancer is particularly high among certain groups. Findings will provide much-needed evidence for anal cancer screening strategies to reduce incidence of anal cancer and improve health outcomes. The study population includes individuals with chronic impairment of the immune system and females with a known history of high-grade lower genital tract neoplasia.
The study procedures include filling out self-reported questionnaires and collecting biosamples for study-related assays. HRA is part of the standard clinic procedure for this group of participants. Collected biosamples will be banked for future research use. In-person or remote signed consent may occur for the study.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Men with impaired immune status | Other | Diagnostic Test: HRA + Biopsy, Diagnostic Test: Anal Cytology, Diagnostic Test: Genotyping of anal hrHPV infection, Diagnostic Test: CINtec®PLUSAt each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. |
| Men without impaired immune status | Other | Diagnostic Test: HRA + Biopsy, Diagnostic Test: Anal Cytology, Diagnostic Test: Genotyping of anal hrHPV infection, Diagnostic Test: CINtec®PLUSAt each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. |
| Women with impaired immune status and and lower genital tract neoplasia (LGTN) | Other | Diagnostic Test: HRA + Biopsy, Diagnostic Test: Anal Cytology, Diagnostic Test: Genotyping of anal hrHPV infection, Diagnostic Test: CINtec®PLUSAt each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. |
| Women without impaired immune status and lower genital tract neoplasia (LGTN) | Other | Diagnostic Test: HRA + Biopsy, Diagnostic Test: Anal Cytology, Diagnostic Test: Genotyping of anal hrHPV infection, Diagnostic Test: CINtec®PLUSAt each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 30-80 years of age
- Individuals with chronic impaired immune status
- History of lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2
Key exclusion criteria (2 listed)
- Patients treated for aHSIL less than 6 months before screening
- History of anal cancer and pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRA + BiopsyAlso: HRA and HistologyHigh-Resolution Anoscopy, or HRA, is a standard of care procedure for screening and detection of premalignant lesions of the anus. Using a small, thin round tube called an anoscope, the anal canal is examined with a high-resolution magnifying instrument called a colposcope. The application of a mildly acidic liquid on the anal canal facilitates the evaluation of abnormal tissue such as anal dysplasia. Biopsies for histological confirmation of disease will be taken. Biopsies' reporting will follow the terminology, criteria, and recommendations of the Lower Anogenital Squamous Terminology (LAST) project. Histology results will be reported as benign, condyloma acuminatum, AIN grades 1-3, or cancer. For the proposed project, aHSIL+ will be defined as AIN2 (p16 block-positive), AIN3, and cancer at the HRA encounter. All other cases will be classified as <aHSIL, including benign, condyloma acuminatum, and AIN1 | Diagnostic test | Men with impaired immune status, Men without impaired immune status, Women with impaired immune status and and lower genital tract neoplasia (LGTN), Women without impaired immune status and lower genital tract neoplasia (LGTN) |
| Anal CytologyAlso: Swab anal SampleAnal cytology collection (swab samples) will be performed as part of the standard of care during this study. The collected cells, suspended in the SurePath liquid-based medium, will be placed on a slide and microscopically examined by a board-certified pathologist. The sample will then be interpreted using the Bethesda System: negative for intraepithelial lesion or malignancy (NILM), ASCUS, LSIL, ASC-H, or HSIL. Pathologists interpreting the anal cytology will be blinded from hrHPV testing and biopsy histology. | Diagnostic test | Men with impaired immune status, Men without impaired immune status, Women with impaired immune status and and lower genital tract neoplasia (LGTN), Women without impaired immune status and lower genital tract neoplasia (LGTN) |
| Genotyping of anal hrHPV infectionAlso: hrHPVSamples of exfoliated cells from the anal canal will be collected with Dacron swabs. To identify the infecting HPV genotype, DNA will be extracted from swab samples collected with the MagNA Pure LC DNA Isolation Kit III and an LC MagNA Pure system (Roche Diagnostics GmbH, Mannheim, Germany), followed by HPV typing using the TypeSeq assay, a laboratory prepared high-throughput next-generation sequencing assay developed by NCI will be performed as described. The assay uses three sequential PCR steps resulting in barcoded L1 amplicons sequenced and submitted to a bioinformatics pipeline for typing. This TypeSeq assay qualitatively detects and identifies 51 HPV genotypes (HPV types 3, 6, 11, 13, 16, 18, 26, 28, 30, 31, 32, 33, 34, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 67, 68, 69, 70, 71, 72, 73, 74, 76, 81, 82, 83, 84, 85, 86, 87, 89, 90, 91, 97, and 114), including 14 high-risk (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) | Diagnostic test | Men with impaired immune status, Men without impaired immune status, Women with impaired immune status and and lower genital tract neoplasia (LGTN), Women without impaired immune status and lower genital tract neoplasia (LGTN) |
| CINtec®PLUSAlso: P16/Ki-67 dual immunostainingSamples of exfoliated cells from the anal canal will be collected with Dacron swabs. Dual immunostaining with p16/Ki-67 will be performed on the residual cytologic specimen by Roche MTM Laboratories (Heidelberg, Germany), using the CINtec®PLUS Kit according to the manufacturer's instructions. The anal cytology material will be stained with a mouse monoclonal antibody directed against human p16INKa (p16) protein (clone E6H4) and recombinant rabbit monoclonal antibody directed against human Ki-67 protein (clone 274-11AC3V1), using the BenchMark ULTRA instrument (Ventana Roche). Samples with insufficient cellularity will be excluded from the evaluation. A trained cytotechnologist will review all cases for cells staining positively with both markers. A slide will be considered positive if 1 or more squamous epithelial cell(s) stained positive for both p16 and Ki-67 and dual stain-positive cells will be semi-quantitatively assessed (0, 1, 2-5, 6-50, >50). | Diagnostic test | Men with impaired immune status, Men without impaired immune status, Women with impaired immune status and and lower genital tract neoplasia (LGTN), Women without impaired immune status and lower genital tract neoplasia (LGTN) |
Primary outcome
Specificity and Sensitivity of screening markers
Time frame: Baseline
Sensitivity and specificity will be calculated for each of the proposed screening markers separately and a combination of two and three markers for the detection of aHSIL at baseline. The combination of the two and three markers of primary interest includes CINtec®PLUS +hrHPV, CINtec®PLUS+anal cytology, hrHPV+anal cytology, and CINtec®PLUS+hrHPV+anal cytology. The analysis will be performed for the four high-risk groups together and stratified by the four high-risk categories.
7 secondary outcomes
DNA methylation markers
Time frame: Baseline, 1 year, 2 years
Anal immune modulations
Time frame: Baseline, 1 year, 2 years
aHSIL prevalence
Time frame: Baseline
aHSIL clearance
Time frame: 1 year, 2 years
Inflammatory Markers (Il-1RA, IL1β, IL6, IL6sr, TNF-α, and IL-10)
Time frame: Baseline, 1 year, 2 years
Inflammatory Markers (sTNFR2 and interferon (IFN)-γ)
Time frame: Baseline, 1 year, 2 years
Inflammatory Marker (CRP)
Time frame: Baseline, 1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected from study participation will be available for sharing after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Flowers, MD, MPH principal investigator
Emory University
Canhua Xiao, PhD, RN principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRA + Biopsy, Anal Cytology and Genotyping of anal hrHPV infection in people with Neoplasms and HPV-Related Anal Squamous Cell Carcinoma, run by Lisa Flowers at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Flowers, MD, MPH (404-251-8931, lflowe2@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity and Sensitivity of screening markers (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.