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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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313104

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

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01313104     History of Changes
Other Study ID Numbers: NU 10G02, NCI-2011-00112, STU00039225
Study First Received: March 9, 2011
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013