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OpenTrials
Completed

NCT Number: NCT00601601

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Done at the completion of the study.

  2. 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

    Time frame: Done at the completion of the study.

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

    Time frame: Done at the completion of the study.

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

    Time frame: Done at the completion of the study.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2011
First posted
Jan 28, 2008
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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