Anal CancerNCT04090060
The Prevent Anal Cancer Palpation Study
A study testing Practice Self-/Companion Exams in people with Anal Cancer, run by Medical College of Wisconsin at 4 sites in United States.
Trial summary
Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. Read more about this study
- Who is it for?
- Ages 25 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Practice Self-/Companion Exams
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jan 2020to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chicago or Houston Metro Residents
- Persons who had sex with men in the prior five years
- Cis-gendered men and transgender persons
- Age: 25 years and over
- Access to medical care for referral or treatment
- Spanish or English speakers/readers
Show all 9Show fewer
- Individuals or couples
- HIV+ or HIV-
- Persons with or without comorbidities and physical disabilities
Who cannot join
- Unresolved health care provider's diagnosis of anal condyloma, hemorrhoids or anal cancer
- DARE in the prior three months
- Plans to move in the following six months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
M.D. Anderson Cancer Center
Houston, Texas, 77030
Gordon Crofoot MD
Houston, Texas, 77098
About this study
Official title: Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.
Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.
Read the detailed description
Even though expert opinion recommends annual digital ano-rectal exams (DARE) for detection of anal cancer tumors among men having sex with men (MSM), the procedure is severely underutilized by clinicians and it is not known how to increase utilization. This is problematic in the context of an extremely high incidence of anal cancer among MSM, no proven treatment for anal precancerous lesions, and lack of screening infrastructure for detecting precancerous lesions, even in high-resource countries.
The long-term goal of this study is to decrease morbidity and mortality from anal cancer by increasing detection of anal canal tumors through self- or partner-palpation of the anal canal. Preliminary data indicate these exams are feasible and highly acceptable among MSM. In a diverse sample of 200 MSM, 93% of men correctly classified their anal self-exam (ASE) or anal companion exam (ACE) as either normal or abnormal, and 94% said the exams were acceptable. Given these findings, our overall objective is to determine the viability of the ASE and ACE by assessing exam accuracy and consistency of results in two clinic sites. Accuracy will be defined as concordance between clinician DARE and participant exam. The central hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits. We will test the hypothesis with three specific aims: 1) Estimate ASE and ACE sensitivity and specificity; 2) Determine independent factors associated with ASE and ACE concordance; and 3) Determine the impact of ASE, ACE, and DARE on survival and quality of life, and evaluate the cost-effectiveness of these strategies among HIV+ and HIV- MSM and transgender persons. The aims will be accomplished with a study in Houston and Chicago with a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged >=25 years, who will perform a clinician-taught ASE or ACE. The individual's ASE and partner's ACE will then be compared with the clinician's DARE. The assessment will be done at each of two visits, spaced six-months apart, to assess retention of exam accuracy.
At the end of visit 1, one-half of participants, i.e., 300 individuals and 50 couples (stratified by city) will be randomly selected and encouraged to practice the ASE/ACE three months before Visit 2. Study staff will make reminder calls (or emails/texts) and follow-up calls for the scheduled practice session. At the follow-up calls, study staff will record the participant's result for the self/companion exam and the level of anxiety and pain, if any, associated with the exam. If the participant reports more than minimal pain and anxiety, they will be asked to return to the clinic for an exam. Regardless of prior results, all persons will be asked to return for Visit 2.
- Conditions
- Anal Cancer
- Being tested
- Practice Self-/Companion Exams, Control Arm
- Keywords
- Anus neoplasm, Digital anal rectal examination, Self anal examination
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice Self-/Companion ExamsBehavioural
300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
Control ArmBehavioural
300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
| Study group | Role | What they receive |
|---|---|---|
| Practice Self-/Companion Exams | Experimental | 300 individuals and 50 couples will be randomized to practice arm. Receives: Behavioral: Practice Self-/Companion Exams |
| Control Arm | Other | 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. Receives: Behavioral: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance Between Self-examination and Clinician Examination
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Measured: Day 1
Concordance Between Self-examination and Clinician Examination
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Measured: Day 180.
Concordance Between Companion Examination and Clinician Examination
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.
Measured: Day 1
Concordance Between Companion Examination and Clinician Examination
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.
Measured: Day 180
Number of Persons Who Practice the Self Examination
This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.
Measured: Day 180
Number of Persons Who Practice the Companion Examination
This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.
Measured: Day 180
Secondary outcomes (4)
Measuring the Difference Between Chicago and Houston Self-exam Concordance.
This measure will count the number of subjects in outcome measures 1, 2, 5 and 9 comparing subjects living in the Chicago and Houston metropolitan areas.
Measured: Day 1
Measuring the Difference Between Chicago and Houston Companion Exam Concordance.
This measure will count the number of subjects in outcome measures 3, 4, 6 and 9 comparing companions living in the Chicago and Houston metropolitan areas.
Measured: Day 1
Waist Circumference for Persons Doing Self-examinations
This measure will record subject waist circumference in cm.
Measured: Day 1
Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.
This measure will record the number of concordant digital anal examination results in persons with less than or equal to 102 cm waist size versus greater than 102 cm waist size. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start17 Jan 2020
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).
- Masking
- None (open label)
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, Gordon Crofoot MD PA, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alan Nyitray, PhD, Medical College of Wisconsin
- Investigators
- Alan Nyitray, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090060
- Sponsor's protocol ID
- PRO00033000
- Other IDs
- R01CA232892-01
- Status last verified
- Jun 2024
- First submitted
- 5 Sep 2019
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa L, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: an observational study. BMJ Public Health. 2024 Jul 12;2(1):e001039. doi: 10.1136/bmjph-2024-001039. eCollection 2024 Jun.
PubMed 40018098Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa LR, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: An observational study. medRxiv [Preprint]. 2024 Feb 1:2024.01.31.24302098. doi: 10.1101/2024.01.31.24302098.
PubMed 38352524
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.
- ClinicalTrials.gov ID
- NCT04090060
- Acronym / sponsor ID
- PRO00033000
- Conditions
- Anal Cancer
- Keywords
- Anus neoplasm, Digital anal rectal examination, Self anal examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of Chicago, M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, Gordon Crofoot MD PA, National Cancer Institute (NCI)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 9 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.
Detailed description
Even though expert opinion recommends annual digital ano-rectal exams (DARE) for detection of anal cancer tumors among men having sex with men (MSM), the procedure is severely underutilized by clinicians and it is not known how to increase utilization. This is problematic in the context of an extremely high incidence of anal cancer among MSM, no proven treatment for anal precancerous lesions, and lack of screening infrastructure for detecting precancerous lesions, even in high-resource countries.
The long-term goal of this study is to decrease morbidity and mortality from anal cancer by increasing detection of anal canal tumors through self- or partner-palpation of the anal canal. Preliminary data indicate these exams are feasible and highly acceptable among MSM. In a diverse sample of 200 MSM, 93% of men correctly classified their anal self-exam (ASE) or anal companion exam (ACE) as either normal or abnormal, and 94% said the exams were acceptable. Given these findings, our overall objective is to determine the viability of the ASE and ACE by assessing exam accuracy and consistency of results in two clinic sites. Accuracy will be defined as concordance between clinician DARE and participant exam. The central hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits. We will test the hypothesis with three specific aims: 1) Estimate ASE and ACE sensitivity and specificity; 2) Determine independent factors associated with ASE and ACE concordance; and 3) Determine the impact of ASE, ACE, and DARE on survival and quality of life, and evaluate the cost-effectiveness of these strategies among HIV+ and HIV- MSM and transgender persons. The aims will be accomplished with a study in Houston and Chicago with a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged >=25 years, who will perform a clinician-taught ASE or ACE. The individual's ASE and partner's ACE will then be compared with the clinician's DARE. The assessment will be done at each of two visits, spaced six-months apart, to assess retention of exam accuracy.
At the end of visit 1, one-half of participants, i.e., 300 individuals and 50 couples (stratified by city) will be randomly selected and encouraged to practice the ASE/ACE three months before Visit 2. Study staff will make reminder calls (or emails/texts) and follow-up calls for the scheduled practice session. At the follow-up calls, study staff will record the participant's result for the self/companion exam and the level of anxiety and pain, if any, associated with the exam. If the participant reports more than minimal pain and anxiety, they will be asked to return to the clinic for an exam. Regardless of prior results, all persons will be asked to return for Visit 2.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).
| Arm | Type | Receives |
|---|---|---|
| Practice Self-/Companion Exams | Experimental | Behavioral: Practice Self-/Companion Exams300 individuals and 50 couples will be randomized to practice arm. |
| Control Arm | Other | Behavioral: Control Arm300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chicago or Houston Metro Residents
- Persons who had sex with men in the prior five years
- Cis-gendered men and transgender persons
- Age: 25 years and over
- Access to medical care for referral or treatment
Key exclusion criteria (3 listed)
- Unresolved health care provider's diagnosis of anal condyloma, hemorrhoids or anal cancer
- DARE in the prior three months
- Plans to move in the following six months
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 |
|---|---|---|
| Practice Self-/Companion Exams300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results. | Behavioural | Practice Self-/Companion Exams |
| Control Arm300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits. | Behavioural | Control Arm |
Primary outcome
Concordance Between Self-examination and Clinician Examination
Time frame: Day 1
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Concordance Between Self-examination and Clinician Examination
Time frame: Day 180.
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Concordance Between Companion Examination and Clinician Examination
Time frame: Day 1
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.
Concordance Between Companion Examination and Clinician Examination
Time frame: Day 180
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.
Number of Persons Who Practice the Self Examination
Time frame: Day 180
This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.
Number of Persons Who Practice the Companion Examination
Time frame: Day 180
This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.
4 secondary outcomes
Measuring the Difference Between Chicago and Houston Self-exam Concordance.
Time frame: Day 1
Measuring the Difference Between Chicago and Houston Companion Exam Concordance.
Time frame: Day 1
Waist Circumference for Persons Doing Self-examinations
Time frame: Day 1
Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40018098Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa L, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: an observational study. BMJ Public Health. 2024 Jul 12;2(1):e001039. doi: 10.1136/bmjph-2024-001039. eCollection 2024 Jun.
- Derived from this study: PubMed 38352524Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa LR, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: An observational study. medRxiv [Preprint]. 2024 Feb 1:2024.01.31.24302098. doi: 10.1101/2024.01.31.24302098.
- Individual participant dataSharing planned: No
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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 Nyitray, PhD principal investigator
Medical College of Wisconsin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Self-/Companion Exams in people with Anal Cancer, run by Medical College of Wisconsin 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 9 inclusion and 3 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 9 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concordance Between Self-examination and Clinician Examination (time frame: Day 1). The study lists 6 primary outcomes in all. 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 NCT04090060, which also lists 2 linked publications.
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 9 Jul 2024.