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This study has been withdrawn prior to enrollment.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:
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

March 9, 2011
June 8, 2012
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  • 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 ]
Same as current
Complete list of historical versions of study NCT01313104 on ClinicalTrials.gov 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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Interventions:
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01313104
NU 10G02, NCI-2011-00112, STU00039225
Yes
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