Anal Canal HPV Infection DiagnosisNCT01104181
Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test
A study testing HC2 collection kit with a swab or brush in people with Anal Canal HPV Infection Diagnosis and Anal Dysplasia Diagnosis, run by Laser Surgery Care at 1 site in United States.
Trial summary
This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anal Canal HPV Infection Diagnosis, Anal Dysplasia Diagnosis, Anal Cancer
- What is being tested?
- HC2 collection kit with a swab or brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female 18 years of age or older
- screened for anal dysplasia, including MSM and women -
Who cannot join
- subject has had a previous treatment for anal cancer.
- subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection.
- subjects that have bleeding disorders or use anticoagulation treatments. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)
This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.
- Being tested
- HC2 collection kit with a swab or brush
- Keywords
- Anal HPV, Anal Dysplasia, Ana Cancer
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC2 collection kit with a swab or brushDevice
Also called Qiagen HC2 HPV High-Risk DNA Test
We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior
| Study group | Role | What they receive |
|---|---|---|
| swab and brush or swab and swab | Experimental | we will determine which collection method is superior Receives: Device: HC2 collection kit with a swab or brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
HC2 can accurately test for oncogenic HPV in anal specimens
Determination that HC2 testing in the anal canal can be performed
Measured: in approximately 12 months
Secondary outcomes (1)
Sensitivity and specificity of cytology with HC2
To determine if HC2 improves the sensitivity and specificity of anal cytology
Measured: in approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Canal HPV Infection DiagnosisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laser Surgery Care
- Sponsor type
- University, hospital or other
- Collaborators
- QIAGEN Gaithersburg, Inc
- Investigators
- Stephen E Goldstone, MD, Principal investigator, Mount Sinai Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104181
- Sponsor's protocol ID
- R09-HPV-001
- Status last verified
- Jun 2011
- First submitted
- 25 Mar 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)
- ClinicalTrials.gov ID
- NCT01104181
- Acronym / sponsor ID
- R09-HPV-001
- Keywords
- Anal HPV, Anal Dysplasia, Ana Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Laser Surgery CareUniversity, hospital or other
- Collaborators
- QIAGEN Gaithersburg, Inc
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Apr 2010 (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.
This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| swab and brush or swab and swab | Experimental | Device: HC2 collection kit with a swab or brushwe will determine which collection method is superior |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female 18 years of age or older
- screened for anal dysplasia, including MSM and women -
Key exclusion criteria (3 listed)
- subject has had a previous treatment for anal cancer.
- subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection.
- subjects that have bleeding disorders or use anticoagulation treatments. -
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 |
|---|---|---|
| HC2 collection kit with a swab or brushAlso: Qiagen HC2 HPV High-Risk DNA TestWe will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior | Device | swab and brush or swab and swab |
Primary outcome
HC2 can accurately test for oncogenic HPV in anal specimens
Time frame: in approximately 12 months
Determination that HC2 testing in the anal canal can be performed
1 secondary outcome
Sensitivity and specificity of cytology with HC2
Time frame: in approximately 12 months
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 22 Jun 2011.
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.
Stephen E Goldstone, MD principal investigator
Mount Sinai Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HC2 collection kit with a swab or brush in people with Anal Canal HPV Infection Diagnosis and Anal Dysplasia Diagnosis, run by Laser Surgery Care 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 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 22 Jun 2011. 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?
HC2 can accurately test for oncogenic HPV in anal specimens (time frame: in approximately 12 months). 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 22 Jun 2011.