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Recruitment Status : Withdrawn (Lack of funding)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

March 9, 2011
March 11, 2011
June 11, 2012
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  • Risk of anal dysplasia in women with cervical or vulvar dysplasia [ Time Frame: Over 2 years ]
  • HPV (Human Papillomavirus) status [ Time Frame: Over 2 years ]
Same as current
Complete list of historical versions of study NCT01313104 on Archive Site
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Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer
Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia
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


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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • 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
    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
Experimental: Screening
See Detailed Description
  • Procedure: colposcopy
  • Other: cervical Papanicolaou test
  • Procedure: screening method
  • Procedure: screening method
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
NU 10G02
NCI-2011-00112 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STU00039225 ( Other Identifier: Northwestern University IRB )
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Northwestern University
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Amy Halverson Northwestern University
Northwestern University
June 2012

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