Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix

Genomics Approach to Id Novel Targets & Markers for Early Detection And Intervention In Cancer (Cervical)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00601601

Enrollment

Registered

2008-01-28

Start date

2004-12-31

Completion date

2011-05-31

Last updated

2012-03-09

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

Conditions

Cervical Cancer, Precancerous Condition

Keywords

stage 0 cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3

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.

Detailed description

OBJECTIVES: Primary * To identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer. * To 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. Secondary * To complete genome scans at high density and analysis of gene and protein expression to identify recurrent genetic and protein changes in cancer. * To confirm changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes. OUTLINE: Patients undergo biopsy of cervical tissue followed by loop electrocautery excision procedure (LEEP) (removing all of the tissue surrounding and under the area biopsied). RNA, DNA, and protein is extracted from the cells to provide material for the construction of libraries for Serial Analysis of Gene Expression (SAGE analysis); for hybridization against Bacterial Artificial Chromosome Comparative Genome Hybridization arrays (BAC CGH arrays); and for analysis using protein chip arrays and proteomics. Resulting data from coded samples provide gene expression and protein profiles. The coded molecular datasets are linked, analyzed, and compared using a variety of statistical software to identify putative genes, gene alterations, and proteins of interest. Some samples may be banked for future studies.

Interventions

None listed

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.
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.

Outcome results