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

Northwestern University

Status: Withdrawn

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

Treatments: Procedure: colposcopy; Procedure: screening method; Other: cervical Papanicolaou test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01313104

NU 10G02

STU00039225 (Other Identifier)

NCI-2011-00112 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Screening

Experimental group

Description:

See Detailed Description

Treatment:

Procedure: screening method

Procedure: screening method

Other: cervical Papanicolaou test

Procedure: colposcopy