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

This study has been withdrawn prior to enrollment.

(Lack of funding)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Northwestern University

ClinicalTrials.gov Identifier:

NCT01313104

First received: March 9, 2011

Last updated: June 8, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2011

Last Updated Date

June 8, 2012

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Risk of anal dysplasia in women with cervical or vulvar dysplasia [ Time Frame: Over 2 years ] [ Designated as safety issue: No ]
HPV (Human Papillomavirus) status [ Time Frame: Over 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01313104 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening

Condition ^ICMJE

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 ^ICMJE

Procedure: colposcopy
Undergo colposcopy
Other: cervical Papanicolaou test
Undergo cervical Pap smear

Other Name: cervical Pap test
Procedure: screening method
Undergo anal Pap smear
Procedure: screening method
Undergo high resolution anoscopy

Study Arm (s)

Experimental: Screening

See Detailed Description

Interventions:

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01313104

Other Study ID Numbers ^ICMJE

NU 10G02, NCI-2011-00112, STU00039225

Has Data Monitoring Committee

Yes

Responsible Party

Northwestern University

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Amy Halverson

Northwestern University

Information Provided By

Northwestern University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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