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WithdrawnNCT01313104Updated Jun 11, 2012

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

An interventional study of colposcopy and cervical Papanicolaou test in Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2 and Cervical Intraepithelial Neoplasia Grade 3, sponsored by Northwestern University. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-11.

Sponsored by Northwestern University · Not applicable, Interventional, and Screening

Why this study was withdrawn
Lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • 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
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Women who are not able to consent are excluded
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Screening

    See Detailed Description

    Procedure: colposcopy · Other: cervical Papanicolaou test · Procedure: screening method

Interventions

  • Procedurecolposcopy

    Undergo colposcopy

  • Othercervical Papanicolaou test

    Undergo cervical Pap smear

    Also known as: cervical Pap test

  • Procedurescreening method

    Undergo anal Pap smear

  • Procedurescreening method

    Undergo high resolution anoscopy

06

What researchers measure

Primary outcomes

  1. Risk of anal dysplasia in women with cervical or vulvar dysplasia

    Time frame: Over 2 years

  2. HPV (Human Papillomavirus) status

    Time frame: Over 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01313104
Lead sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 11, 2011
Last update
Jun 11, 2012

Study contacts

Amy Halverson
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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