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NCT01313104 Clinical Trial

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

Stage IVA Cervical Cancer Clinical Trial

Official title:
Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01313104
Other study ID # NU 10G02
Secondary ID NCI-2011-00112ST
Status Withdrawn
Phase N/A
First received March 9, 2011
Last updated June 8, 2012

Study information
Verified date June 2012
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

  • Carcinoma in Situ
  • Cervical Intraepithelial Neoplasia
  • Cervical Intraepithelial Neoplasia Grade 1
  • Cervical Intraepithelial Neoplasia Grade 2
  • Cervical Intraepithelial Neoplasia Grade 3
  • Neoplasms
  • 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
  • Uterine Cervical Dysplasia
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms

Intervention

Procedure:
• colposcopy
Undergo colposcopy
Other:
• cervical Papanicolaou test
Undergo cervical Pap smear
Procedure:
• screening method
Undergo anal Pap smear
• screening method
Undergo high resolution anoscopy

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Northwestern University National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Risk of anal dysplasia in women with cervical or vulvar dysplasia Over 2 years No
Primary HPV (Human Papillomavirus) status Over 2 years No
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