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

Not Applicable

Withdrawn

• 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; Stage 0 Cervical Cancer; Stage 0 Vaginal Cancer; Stage 0 Vulvar Cancer; Stage I Vaginal Cancer
• Interventions: Procedure: colposcopy; Other: cervical Papanicolaou test; Procedure: screening method

• Registration Number: NCT01313104
• Lead Sponsor: Northwestern University

Brief 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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-08
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Women who are not able to consent are excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening	colposcopy	See Detailed Description
Screening	cervical Papanicolaou test	See Detailed Description
Screening	screening method	See Detailed Description

Primary Outcome Measures

Name	Time	Method
HPV (Human Papillomavirus) status	Over 2 years
Risk of anal dysplasia in women with cervical or vulvar dysplasia	Over 2 years