Anal CancerNCT00955591
Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men
A study testing Papanicolaou test in people with Anal Cancer and Nonneoplastic Condition, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Cancer, Nonneoplastic Condition, Precancerous Condition
- What is being tested?
- Papanicolaou test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2009to 14 Oct 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-infected or -uninfected adult men who have sex with men
- Concurrent enrollment in the Multicenter AIDS Cohort Study required
Who cannot join
- history of anal perforation or other medical contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.
PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.
Read the detailed description
OBJECTIVES:
- To determine whether the anal cytology screening outcome derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens in men who have sex with men.
- To determine whether the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens.
OUTLINE: Dry sterile Dacron swabs and flocked nylon swabs are used to collect intra-anal cytology specimens for anal Pap testing and human papillomavirus typing. Participants undergo a digital rectal examination and high-resolution anoscopy. If lesions are identified, an anal biopsy is performed for histological examination.
- Conditions
- Anal Cancer, Nonneoplastic Condition, Precancerous Condition
- Being tested
- Papanicolaou test
- Keywords
- human papilloma virus infection, anal cancer, HIV infection
- Medical subject headings
- Anus Neoplasms, Precancerous Conditions, Papillomavirus Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papanicolaou testOther
| Study group | Role | What they receive |
|---|---|---|
| swab test | Other | Not described Receives: Other: Papanicolaou test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
Measured: a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study start12 Mar 2009
- Primary completion12 Dec 2011
- Study completion14 Oct 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 Anal CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Wiley, Ph.D. RN, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955591
- Sponsor's protocol ID
- CDR0000643881
- Other IDs
- UCLA-0901062, IRB# 09-01-062-02
- Status last verified
- Sep 2016
- First submitted
- 7 Aug 2009
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wiley DJ, Hsu H, Bolan R, Voskanian A, Elashoff D, Young S, Dayrit R, Barman P, DeAzambuja K, Masongsong EV, Martinez-Maza O, Detels R. Comparison of 2 anal cytology protocols to predict high-grade anal intraepithelial neoplasia. J Low Genit Tract Dis. 2013 Oct;17(4):414-24. doi: 10.1097/LGT.0b013e318281d36e.
PubMed 23595039
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
- ClinicalTrials.gov ID
- NCT00955591
- Acronym / sponsor ID
- CDR0000643881
- Conditions
- Anal Cancer, Nonneoplastic Condition, Precancerous Condition
- Keywords
- human papilloma virus infection, anal cancer, HIV infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Mar 2009 (actual)
- Primary completion
- 12 Dec 2011 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 10 Aug 2009 (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.
RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.
PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.
Detailed description
OBJECTIVES:
- To determine whether the anal cytology screening outcome derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens in men who have sex with men.
- To determine whether the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens.
OUTLINE: Dry sterile Dacron swabs and flocked nylon swabs are used to collect intra-anal cytology specimens for anal Pap testing and human papillomavirus typing. Participants undergo a digital rectal examination and high-resolution anoscopy. If lesions are identified, an anal biopsy is performed for histological examination.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| swab test | Other | Other: Papanicolaou test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-infected or -uninfected adult men who have sex with men
- Concurrent enrollment in the Multicenter AIDS Cohort Study required
Key exclusion criteria (1 listed)
- history of anal perforation or other medical contraindications
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 |
|---|---|---|
| Papanicolaou test | Other | swab test |
Primary outcome
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
Time frame: a day
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 3 Aug 2020.
- Derived from this study: PubMed 23595039Wiley DJ, Hsu H, Bolan R, Voskanian A, Elashoff D, Young S, Dayrit R, Barman P, DeAzambuja K, Masongsong EV, Martinez-Maza O, Detels R. Comparison of 2 anal cytology protocols to predict high-grade anal intraepithelial neoplasia. J Low Genit Tract Dis. 2013 Oct;17(4):414-24. doi: 10.1097/LGT.0b013e318281d36e.
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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.
Dorothy Wiley, Ph.D. RN principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papanicolaou test in people with Anal Cancer and Nonneoplastic Condition, run by Jonsson Comprehensive Cancer Center 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 2 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 3 Aug 2020. 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?
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab (time frame: a day). 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 NCT00955591, 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 3 Aug 2020.