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

Primary Purpose

Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2, Cervical Intraepithelial Neoplasia Grade 3

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
colposcopy
cervical Papanicolaou test
screening method
screening method
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Intraepithelial Neoplasia Grade 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Screening

    Arm Description

    See Detailed Description

    Outcomes

    Primary Outcome Measures

    Risk of anal dysplasia in women with cervical or vulvar dysplasia
    HPV (Human Papillomavirus) status

    Secondary Outcome Measures

    Full Information

    First Posted
    March 9, 2011
    Last Updated
    June 8, 2012
    Sponsor
    Northwestern University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01313104
    Brief Title
    Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer
    Official Title
    Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northwestern University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Screening
    Arm Type
    Experimental
    Arm Description
    See Detailed Description
    Intervention Type
    Procedure
    Intervention Name(s)
    colposcopy
    Intervention Description
    Undergo colposcopy
    Intervention Type
    Other
    Intervention Name(s)
    cervical Papanicolaou test
    Other Intervention Name(s)
    cervical Pap test
    Intervention Description
    Undergo cervical Pap smear
    Intervention Type
    Procedure
    Intervention Name(s)
    screening method
    Intervention Description
    Undergo anal Pap smear
    Intervention Type
    Procedure
    Intervention Name(s)
    screening method
    Intervention Description
    Undergo high resolution anoscopy
    Primary Outcome Measure Information:
    Title
    Risk of anal dysplasia in women with cervical or vulvar dysplasia
    Time Frame
    Over 2 years
    Title
    HPV (Human Papillomavirus) status
    Time Frame
    Over 2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy Halverson
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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