Anus NeoplasmsNCT02384005
The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
A study testing Self-anal exam arm in people with Anus Neoplasms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
There is no standard screening protocol for anal cancer even as disease incidence increases. This single-visit study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability. Read more about this study
- Who is it for?
- Ages 27 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anus Neoplasms
- What is being tested?
- Self-anal exam arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 27 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men who are aged 27-80 years
- Acknowledge sex with men in their lifetime
- Reside in Harris County, Texas
- Understand and speak English.
Who cannot join
- Current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas School of Public Health
Houston, Texas, 77030
About this study
There is no standard screening protocol for anal cancer even as disease incidence increases. This single-visit study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability.
The investigators hypothesize that men having sex with men's digital anal exam (DAE) findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis the investigator believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person.
Read the detailed description
There is no standard screening protocol for anal cancer even as disease incidence and mortality increases; however, a digital anorectal exam (also called a digital rectal exam) will play a role in any recommended protocol. Critically, fewer digital anorectal exams are being performed by physicians even though it is a simple and quick procedure. If men who have sex with men (MSM) can learn to examine the anal canal, then detection and treatment of early cancers among this population may increase. This single-visit Phase II feasibility study will investigate increasing digital anal exam (DAE) use to enhance screening for anal cancer among MSM aged 27-80 years. The investigators hypothesize that MSM's DAE findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis the investigators believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person. It is not proposed that lay persons recognize specific conditions but, rather, that any abnormality should trigger a doctor visit. The specific aims are:
- Estimate the agreement between the digital anal exams of 200 MSM and the gold standard of a highly experienced nurse practitioner during a single clinical visit. This aim will answer the question: under optimal circumstances, will MSM report accurate findings after performing their own DAE?
- Determine factors independently associated with concordance of MSM and nurse practitioner DAEs including age, single men vs. men in couples, race, ethnicity and waist circumference. This aim will provide insight into which MSM are more likely to perform accurate DAEs.
- Assess DAE acceptability, self-efficacy, safety, and intentions-to-seek subsequent care.
This aim will answer the question: will lay-performed DAEs have sufficient acceptability and safety and trigger appropriate follow-up care?
The goal is to advance knowledge of how to increase use of digital anal exams to reduce anal cancer morbidity and mortality. The study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability.
- Conditions
- Anus Neoplasms
- Being tested
- Self-anal exam arm
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-anal exam armOther
After a short pre-test the clinician will use a model to show a normal and diseased anal canal and then use pictures to show a self-DAE. The clinician will describe how to do a self-DAE for single men and partners. Next, the clinician will ask the participant to lower his pants for collection of anal human papillomavirus (HPV) DNA and cytology. The clinician will conduct a DAE and then participants will do self-DAE done in private. Then the research assistant will demonstrate the computer-assisted self-interview. When participants return to the clinician to receive the DAE results, the clinician will conduct a safety-related interview. The clinician will treat external anal disease, triage internal anal disease, and ask to be notified if a participant has any anus-related concerns in the following week. A complete appointment will require 70 minutes for singles and 105 minutes for couples. The PI will later conduct 3 focus groups.
| Study group | Role | What they receive |
|---|---|---|
| Self-anal exam arm | Other | Study only has one arm. Receives: Other: Self-anal exam arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results.
Measured: This cross-sectional design measures agreement on Day 1.
Secondary outcomes (9)
Odds ratios will be calculated for the association between partnership status and concordance between participant and clinician.
Measured: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between age and concordance between participant and clinician.
Measured: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between waist circumference and concordance between participant and clinician.
Measured: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between race and concordance between participant and clinician.
Measured: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between ethnicity and concordance between participant and clinician.
Measured: This cross-sectional design collects data for the odds ratios on Day 1
Number of persons who state that a self-DAE is an acceptable procedure.
Measured: This cross-sectional design collects these data on Day 1
Number of persons with adverse events after conducting a self-DAE.
Measured: This cross-sectional design collects these data on Day 1
Number of persons who state they have the ability to conduct a self-DAE.
Measured: This cross-sectional design collects these data on Day 1
Number of persons who state they intend to seek subsequent care in the event of an abnormal result to a self-DAE.
Measured: This cross-sectional design collects these data on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anus NeoplasmsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Baylor College of Medicine
- Responsible party
- Principal investigator, Alan G Nyitray, The University of Texas Health Science Center, Houston
- Investigators
- Alan G. Nyitray, PhD, Principal investigator, University of Texas School of Public Health at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384005
- Sponsor's protocol ID
- HSC-SPH-13-0671
- Other IDs
- 1R21CA181901-01A1
- Status last verified
- May 2016
- First submitted
- 3 Mar 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nyitray AG, Hicks JT, Hwang LY, Baraniuk S, White M, Millas S, Onwuka N, Zhang X, Brown EL, Ross MW, Chiao EY. A phase II clinical study to assess the feasibility of self and partner anal examinations to detect anal canal abnormalities including anal cancer. Sex Transm Infect. 2018 Mar;94(2):124-130. doi: 10.1136/sextrans-2017-053283. Epub 2017 Aug 23.
PubMed 28835533
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
- ClinicalTrials.gov ID
- NCT02384005
- Acronym / sponsor ID
- HSC-SPH-13-0671
- Conditions
- Anus Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Baylor College of Medicine
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Mar 2015 (estimated)
- 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.
There is no standard screening protocol for anal cancer even as disease incidence increases. This single-visit study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability.
The investigators hypothesize that men having sex with men's digital anal exam (DAE) findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis the investigator believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person.
Detailed description
There is no standard screening protocol for anal cancer even as disease incidence and mortality increases; however, a digital anorectal exam (also called a digital rectal exam) will play a role in any recommended protocol. Critically, fewer digital anorectal exams are being performed by physicians even though it is a simple and quick procedure. If men who have sex with men (MSM) can learn to examine the anal canal, then detection and treatment of early cancers among this population may increase. This single-visit Phase II feasibility study will investigate increasing digital anal exam (DAE) use to enhance screening for anal cancer among MSM aged 27-80 years. The investigators hypothesize that MSM's DAE findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis the investigators believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person. It is not proposed that lay persons recognize specific conditions but, rather, that any abnormality should trigger a doctor visit. The specific aims are:
- Estimate the agreement between the digital anal exams of 200 MSM and the gold standard of a highly experienced nurse practitioner during a single clinical visit. This aim will answer the question: under optimal circumstances, will MSM report accurate findings after performing their own DAE?
- Determine factors independently associated with concordance of MSM and nurse practitioner DAEs including age, single men vs. men in couples, race, ethnicity and waist circumference. This aim will provide insight into which MSM are more likely to perform accurate DAEs.
- Assess DAE acceptability, self-efficacy, safety, and intentions-to-seek subsequent care.
This aim will answer the question: will lay-performed DAEs have sufficient acceptability and safety and trigger appropriate follow-up care?
The goal is to advance knowledge of how to increase use of digital anal exams to reduce anal cancer morbidity and mortality. The study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-anal exam arm | Other | Other: Self-anal exam armStudy only has one arm. |
Who may qualify
- Ages
- 27 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men who are aged 27-80 years
- Acknowledge sex with men in their lifetime
- Reside in Harris County, Texas
- Understand and speak English.
Key exclusion criteria (1 listed)
- Current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer
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 |
|---|---|---|
| Self-anal exam armAfter a short pre-test the clinician will use a model to show a normal and diseased anal canal and then use pictures to show a self-DAE. The clinician will describe how to do a self-DAE for single men and partners. Next, the clinician will ask the participant to lower his pants for collection of anal human papillomavirus (HPV) DNA and cytology. The clinician will conduct a DAE and then participants will do self-DAE done in private. Then the research assistant will demonstrate the computer-assisted self-interview. When participants return to the clinician to receive the DAE results, the clinician will conduct a safety-related interview. The clinician will treat external anal disease, triage internal anal disease, and ask to be notified if a participant has any anus-related concerns in the following week. A complete appointment will require 70 minutes for singles and 105 minutes for couples. The PI will later conduct 3 focus groups. | Other | Self-anal exam arm |
Primary outcome
Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results.
Time frame: This cross-sectional design measures agreement on Day 1.
9 secondary outcomes
Odds ratios will be calculated for the association between partnership status and concordance between participant and clinician.
Time frame: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between age and concordance between participant and clinician.
Time frame: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between waist circumference and concordance between participant and clinician.
Time frame: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between race and concordance between participant and clinician.
Time frame: This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between ethnicity and concordance between participant and clinician.
Time frame: This cross-sectional design collects data for the odds ratios on Day 1
Number of persons who state that a self-DAE is an acceptable procedure.
Time frame: This cross-sectional design collects these data on Day 1
Number of persons with adverse events after conducting a self-DAE.
Time frame: This cross-sectional design collects these data on Day 1
Number of persons who state they have the ability to conduct a self-DAE.
Time frame: This cross-sectional design collects these data on Day 1
Number of persons who state they intend to seek subsequent care in the event of an abnormal result to a self-DAE.
Time frame: This cross-sectional design collects these data on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 28835533Nyitray AG, Hicks JT, Hwang LY, Baraniuk S, White M, Millas S, Onwuka N, Zhang X, Brown EL, Ross MW, Chiao EY. A phase II clinical study to assess the feasibility of self and partner anal examinations to detect anal canal abnormalities including anal cancer. Sex Transm Infect. 2018 Mar;94(2):124-130. doi: 10.1136/sextrans-2017-053283. Epub 2017 Aug 23.
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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. This study is not recruiting at the moment.
Alan G. Nyitray, PhD principal investigator
University of Texas School of Public Health at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-anal exam arm in people with Anus Neoplasms, run by The University of Texas Health Science Center, Houston at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results. (time frame: This cross-sectional design measures agreement on Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384005, which also lists 1 linked publication.
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 12 May 2016.