Cervical Intraepithelial Neoplasia Grade 1NCT01313104
Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer
A study testing colposcopy, cervical Papanicolaou test and screening method in people with Cervical Intraepithelial Neoplasia Grade 1 and Cervical Intraepithelial Neoplasia Grade 2, run by Northwestern University.
Trial summary
This clinical trial studies colposcopy and high resolution anoscopy in screening for anal dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may help doctors find cancer cells early and plan better treatment for cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2, Cervical Intraepithelial Neoplasia Grade 3
- What is being tested?
- colposcopy, cervical Papanicolaou test and screening method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of cervical, vaginal or vulvar intraepithelial neoplasia or cancer are included
- Individuals treated with prior radiation therapy and/or chemotherapy are allowed
- Women with high-grade dysplasia (carcinoma in situ) are eligible, regardless of their dysplasia free interval
- HIV-positive (Human Immunodeficiency Virus) and HIV-negative women will be enrolled; HIV testing will not be performed as part of the study
Who cannot join
- Women who are not able to consent are excluded
About this study
Official title: Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia
This clinical trial studies colposcopy and high resolution anoscopy in screening for anal dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may help doctors find cancer cells early and plan better treatment for cancer
Read the detailed description
OBJECTIVES:
- To evaluate the risk of anal dysplasia in women with cervical or vulvar dysplasia.
OUTLINE:
Patients undergo colposcopy and cervical Papanicolaou test with Human papillomavirus (HPV) test followed by anal Papanicolaou test and high resolution anoscopy. Patients with dysplastic anal lesions undergo repeat anoscopy at 3, 9, 15, and 24 months. Patients with normal anoscopy are followed up at 1 and 2 years.
- Conditions
- Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2, Cervical Intraepithelial Neoplasia Grade 3, Recurrent Cervical Cancer, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer
- Being tested
- colposcopy, cervical Papanicolaou test, screening method
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colposcopyProcedure or surgery
Undergo colposcopy
cervical Papanicolaou testOther
Also called cervical Pap test
Undergo cervical Pap smear
screening methodProcedure or surgery
Undergo anal Pap smear
screening methodProcedure or surgery
Undergo high resolution anoscopy
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | See Detailed Description Receives: Procedure: colposcopy; Other: cervical Papanicolaou test; Procedure: screening method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of anal dysplasia in women with cervical or vulvar dysplasia
Measured: Over 2 years
HPV (Human Papillomavirus) status
Measured: Over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 1Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amy Halverson, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313104
- Sponsor's protocol ID
- NU 10G02
- Other IDs
- NCI-2011-00112, STU00039225
- Status last verified
- Jun 2012
- First submitted
- 9 Mar 2011
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia
- ClinicalTrials.gov ID
- NCT01313104
- Acronym / sponsor ID
- NU 10G02
- Conditions
- Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2, Cervical Intraepithelial Neoplasia Grade 3, Recurrent Cervical Cancer, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 11 Mar 2011 (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 clinical trial studies colposcopy and high resolution anoscopy in screening for anal dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may help doctors find cancer cells early and plan better treatment for cancer
Detailed description
OBJECTIVES:
- To evaluate the risk of anal dysplasia in women with cervical or vulvar dysplasia.
OUTLINE:
Patients undergo colposcopy and cervical Papanicolaou test with Human papillomavirus (HPV) test followed by anal Papanicolaou test and high resolution anoscopy. Patients with dysplastic anal lesions undergo repeat anoscopy at 3, 9, 15, and 24 months. Patients with normal anoscopy are followed up at 1 and 2 years.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Procedure: colposcopy, Other: cervical Papanicolaou test, Procedure: screening methodSee Detailed Description |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological confirmation of cervical, vaginal or vulvar intraepithelial neoplasia or cancer are included
- Individuals treated with prior radiation therapy and/or chemotherapy are allowed
- Women with high-grade dysplasia (carcinoma in situ) are eligible, regardless of their dysplasia free interval
- HIV-positive (Human Immunodeficiency Virus) and HIV-negative women will be enrolled; HIV testing will not be performed as part of the study
Key exclusion criteria (1 listed)
- Women who are not able to consent are excluded
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 |
|---|---|---|
| colposcopyUndergo colposcopy | Procedure or surgery | Screening |
| cervical Papanicolaou testAlso: cervical Pap testUndergo cervical Pap smear | Other | Screening |
| screening methodUndergo anal Pap smear | Procedure or surgery | Screening |
| screening methodUndergo high resolution anoscopy | Procedure or surgery | Screening |
Primary outcome
Risk of anal dysplasia in women with cervical or vulvar dysplasia
Time frame: Over 2 years
HPV (Human Papillomavirus) status
Time frame: Over 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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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.
Amy Halverson principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing colposcopy, cervical Papanicolaou test and screening method in people with Cervical Intraepithelial Neoplasia Grade 1 and Cervical Intraepithelial Neoplasia Grade 2, run by Northwestern University.
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: withdrawn, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Risk of anal dysplasia in women with cervical or vulvar dysplasia (time frame: Over 2 years). The study lists 2 primary outcomes in all. 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 11 Jun 2012.