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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313104
Recruitment Status : Withdrawn (Lack of funding)
First Posted : March 11, 2011
Last Update Posted : June 11, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
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 Procedure: colposcopy Other: cervical Papanicolaou test Procedure: screening method Not Applicable

Detailed Description:


I. To evaluate the risk of anal dysplasia in women with cervical or vulvar dysplasia.


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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia

Arm Intervention/treatment
Experimental: Screening
See Detailed Description
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

Primary Outcome Measures :
  1. Risk of anal dysplasia in women with cervical or vulvar dysplasia [ Time Frame: Over 2 years ]
  2. HPV (Human Papillomavirus) status [ Time Frame: Over 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01313104

Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Amy Halverson Northwestern University

Responsible Party: Northwestern University Identifier: NCT01313104     History of Changes
Other Study ID Numbers: NU 10G02
NCI-2011-00112 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STU00039225 ( Other Identifier: Northwestern University IRB )
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaginal Diseases
Carcinoma in Situ
Uterine Cervical Dysplasia
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
Precancerous Conditions