NCT01313104

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

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

First QC Date

March 9, 2011

Last Update Submit

June 8, 2012

Conditions

Cervical Intraepithelial Neoplasia Grade 1Cervical Intraepithelial Neoplasia Grade 2Cervical Intraepithelial Neoplasia Grade 3Recurrent Cervical CancerRecurrent Vaginal CancerRecurrent Vulvar CancerStage 0 Cervical CancerStage 0 Vaginal CancerStage 0 Vulvar CancerStage I Vaginal CancerStage I Vulvar CancerStage IA Cervical CancerStage IB Cervical CancerStage II Vaginal CancerStage II Vulvar CancerStage IIA Cervical CancerStage IIB Cervical CancerStage III Cervical CancerStage III Vaginal CancerStage III Vulvar CancerStage IV Vulvar CancerStage IVA Cervical CancerStage IVA Vaginal CancerStage IVB Cervical CancerStage IVB Vaginal Cancer

Outcome Measures

Primary Outcomes (2)

  • Risk of anal dysplasia in women with cervical or vulvar dysplasia

    Over 2 years

  • HPV (Human Papillomavirus) status

    Over 2 years

Study Arms (1)

Screening

EXPERIMENTAL

See Detailed Description

Procedure: colposcopyOther: cervical Papanicolaou testProcedure: screening method

Interventions

colposcopyPROCEDURE

Undergo colposcopy

Screening
cervical Papanicolaou testOTHER

Undergo cervical Pap smear

Also known as: cervical Pap test
Screening
screening methodPROCEDURE

Undergo anal Pap smear

Screening

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women who are not able to consent are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Interventions

ColposcopyVaginal SmearsHigh-Throughput Screening Assays

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteVaginal DiseasesVulvar Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical ProceduresBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingInvestigative TechniquesTechnology, Pharmaceutical

Study Officials

  • Amy Halverson

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 11, 2011

Last Updated

June 11, 2012

Record last verified: 2012-06