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

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

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.

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening

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Group Type EXPERIMENTAL

colposcopy

Intervention Type PROCEDURE

Undergo colposcopy

cervical Papanicolaou test

Intervention Type OTHER

Undergo cervical Pap smear

screening method

Intervention Type PROCEDURE

Undergo anal Pap smear

screening method

Intervention Type PROCEDURE

Undergo high resolution anoscopy

Interventions

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colposcopy

Undergo colposcopy

Intervention Type PROCEDURE

cervical Papanicolaou test

Undergo cervical Pap smear

Intervention Type OTHER

screening method

Undergo anal Pap smear

Intervention Type PROCEDURE

screening method

Undergo high resolution anoscopy

Intervention Type PROCEDURE

Other Intervention Names

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cervical Pap test

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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