Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer

Study Overview
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Brief Summary
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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
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OBJECTIVES: 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.

Official Title
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Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia

Conditions
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Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2, Cervical Intraepithelial Neoplasia Grade 3, Recurrent Cervical Cancer, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer, Stage 0 Cervical Cancer, Stage 0 Vaginal Cancer, Stage 0 Vulvar Cancer, Stage I Vaginal Cancer, Stage I Vulvar Cancer, Stage IA Cervical Cancer, Stage IB Cervical Cancer, Stage II Vaginal Cancer, Stage II Vulvar Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Vaginal Cancer, Stage III Vulvar Cancer, Stage IV Vulvar Cancer, Stage IVA Cervical Cancer, Stage IVA Vaginal Cancer, Stage IVB Cervical Cancer, Stage IVB Vaginal Cancer

Intervention / Treatment
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* Procedure: colposcopy
* Other: cervical Papanicolaou test
* Procedure: screening method
* Procedure: screening method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Women who are not able to consent are excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening<br>See Detailed Description | Procedure: colposcopy<br>* Undergo colposcopy<br>Other: cervical Papanicolaou test<br>* Undergo cervical Pap smear<br>* Other names: cervical Pap test;Procedure: screening method<br>* Undergo anal Pap smear<br>Procedure: screening method<br>* Undergo high resolution anoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of anal dysplasia in women with cervical or vulvar dysplasia |  | Over 2 years | 
| HPV (Human Papillomavirus) status |  | Over 2 years |