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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01313104
First Posted: March 11, 2011
Last Update Posted: June 11, 2012
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
  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: 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

Resource links provided by NLM:


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 ]
  • HPV (Human Papillomavirus) status [ Time Frame: Over 2 years ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT01313104


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

Responsible Party: Northwestern University
ClinicalTrials.gov 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 Submitted: March 9, 2011
First Posted: March 11, 2011
Last Update Posted: June 11, 2012
Last Verified: June 2012

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