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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01313104

Enrollment

Registered

2011-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2012-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREcolposcopy

Undergo colposcopy

OTHERcervical Papanicolaou test

Undergo cervical Pap smear

PROCEDUREscreening method

Undergo anal Pap smear

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Risk of anal dysplasia in women with cervical or vulvar dysplasia	Over 2 years
HPV (Human Papillomavirus) status	Over 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026