NCT00900081

Brief Summary

RATIONALE: Studying samples of tissue from patients with or without cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This laboratory study is looking at cyclooxygenase-2 expression in tissue samples from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive cervical cancer.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2003

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

August 1, 2017

Status Verified

October 1, 2015

Enrollment Period

Same day

First QC Date

May 9, 2009

Last Update Submit

July 28, 2017

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical squamous cell carcinomastage IA cervical cancerstage 0 cervical cancercervical intraepithelial neoplasia grade 1cervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (2)

  • Cyclooxygenase-2 (COX-2) levels in cervical intraepithelial neoplasia (CIN)

    day 1

  • Correlation of COX-2 levels in CIN with histological diagnosis and parameters of invasion

    Day 1

Interventions

immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
medical chart reviewOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with Cervical Intraepithelial Neoplasia

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Underwent hysterectomy with removal of a normal cervix for diagnosis unrelated to cancer or cervical dysplasia * Underwent cervical biopsy or removal of cervical tissue and diagnosed with cervical intraepithelial neoplasia (CIN) grades 1-3 * Underwent cervical biopsy and diagnosed with microinvasive squamous cell carcinoma of the cervix * Paraffin-embedded tissue samples of normal cervical epithelium, CIN, or microinvasive squamous cell carcinoma of the cervix must be available for examination PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsUterine Cervical Dysplasia

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Brigitte E. Miller, MD

    Wake Forest University Health Sciences

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2003

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

August 1, 2017

Record last verified: 2015-10