Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer
NCT ID: NCT01313104
Last Updated: 2012-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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I. 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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening
See Detailed Description
colposcopy
Undergo colposcopy
cervical Papanicolaou test
Undergo cervical Pap smear
screening method
Undergo anal Pap smear
screening method
Undergo high resolution anoscopy
Interventions
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colposcopy
Undergo colposcopy
cervical Papanicolaou test
Undergo cervical Pap smear
screening method
Undergo anal Pap smear
screening method
Undergo high resolution anoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Amy Halverson
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Other Identifiers
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NCI-2011-00112
Identifier Type: REGISTRY
Identifier Source: secondary_id
STU00039225
Identifier Type: OTHER
Identifier Source: secondary_id
NU 10G02
Identifier Type: -
Identifier Source: org_study_id
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