NCT00003384

Brief Summary

This diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia and/or cancer. The presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia and/or cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

12.3 years

First QC Date

November 1, 1999

Last Update Submit

May 27, 2015

Conditions

Precancerous ConditionStage 0 Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Expression of the MN antigen in cytologic preparations that have been classified as AGUS

    Baseline

  • Number of cervical specimens identified as having or not having glandular and/or squamous neoplasia

    Baseline

Secondary Outcomes (6)

  • Ability of the MN antigen marker to be able to correctly predict patients who do not have glandular and/or squamous neoplasia

    Up to 2 years

  • Feasibility, based on the number of years required to complete the study, as determined by both the actual disease prevalence rate as well as the actual patient accrual rate

    At 1 year

  • Sensitivity for HIV testing

    Baseline

  • Sensitivity of the expression of the MN antigen

    Baseline

  • Specificity for HIV testing

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Diagnostic

EXPERIMENTAL

Patients undergo a Pap smear followed by a ThinPrep cervical cell specimen collection at the time of direct colposcopic examination. Patients then undergo a cone biopsy of the cervix using loop electrosurgical excision procedure with an endocervical curettage, an excisional cone biopsy of the cervix with or without endocervical curettage, or a hysterectomy. Patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy also undergo endometrial biopsy or curettage. The Pap smear specimen is analyzed to determine MN antigen expression and the ThinPrep specimen is analyzed for the presence of high-risk human papilloma virus and to determine MN antigen and other marker (e.g., P16) expression. Patients who do not undergo hysterectomy are followed every 6 months for 2 years. All other patients are followed at 4, 26, and 30 weeks.

Other: Cervical Papanicolaou TestProcedure: ConizationOther: Laboratory Biomarker Analysis

Interventions

Cervical Papanicolaou TestOTHER

Undergo Pap smear

Also known as: Cervical Pap Test
Diagnostic
ConizationPROCEDURE

Undergo cone biopsy

Also known as: cone biopsy, Cone Biopsy of Cervix, Conization of Cervix, Conization of Uterine Cervix
Diagnostic
Laboratory Biomarker AnalysisOTHER

Correlative studies

Diagnostic

Eligibility Criteria

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

You may qualify if:

  • Cytologically confirmed atypical glandular cells of undetermined significance (AGUS)
  • Must be scheduled to undergo complete histologic examination of the cervix by cone biopsy using loop electrosurgical excision procedure with an endocervical curettage, excisional cone biopsy with or without endocervical curettage, or hysterectomy within 6 months of the initial cytologic diagnosis of AGUS
  • No history of endometrial hyperplasia
  • No history of cancer of the endometrium, vagina, or cervix
  • HIV negative
  • No pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed
  • No prior cytotoxic chemotherapy for vaginal and/or cervical cancer
  • No prior radiotherapy to the vagina or cervix
  • No concurrent radiotherapy to the vagina or cervix
  • No prior hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Precancerous ConditionsUterine Cervical Dysplasia

Interventions

Vaginal SmearsConization

Condition Hierarchy (Ancestors)

NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, Obstetrical and GynecologicalSurgical Procedures, OperativeInvestigative TechniquesDiagnostic Techniques, Surgical

Study Officials

  • Shu-Yuan Liao

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1998

Primary Completion

January 1, 2011

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

US(1)