Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia
18 Years
N/A
Female
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
Trial Information
Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Risk of anal dysplasia in women with cervical or vulvar dysplasia
Outcome Time Frame:
Over 2 years
Safety Issue:
No
Principal Investigator
Amy Halverson
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Institutional Review Board
Study ID:
NU 10G02
NCT ID:
NCT01313104
Start Date:
Completion Date:
Related Keywords:
- 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
- Neoplasms
- Uterine Cervical Neoplasms
- Vaginal Neoplasms
- Vulvar Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Carcinoma in Situ
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