NCT00601601

Brief Summary

RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal cells may help doctors identify biomarkers related to cancer. PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women with cervical dysplasia or carcinoma in situ of the cervix.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

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

December 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

4.3 years

First QC Date

January 25, 2008

Last Update Submit

March 7, 2012

Conditions

Cervical CancerPrecancerous Condition

Keywords

stage 0 cervical cancercervical intraepithelial neoplasia grade 1cervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (4)

  • Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer

    Done at the completion of the study.

  • Identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design

    Done at the completion of the study.

  • Completion of genome scans at high density and analysis of gene and protein expressions to identify recurrent genetic and protein changes in cancer

    Done at the completion of the study.

  • Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes

    Done at the completion of the study.

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP).

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed premalignant lesion, dysplasia, or carcinoma in situ of the cervix * Clinically documented disease * Attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP) PATIENT CHARACTERISTICS: * Not pregnant * No lack of informed consent due to language difficulty, physical and mental condition PRIOR CONCURRENT THERAPY: * No prior operation for removal of the cervix * Concurrent therapy allowed

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

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sylvia Lam

    British Columbia Cancer Agency

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2008

First Posted

January 28, 2008

Study Start

December 1, 2004

Primary Completion

April 1, 2009

Study Completion

May 1, 2011

Last Updated

March 9, 2012

Record last verified: 2012-03