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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00601601
First received: January 25, 2008
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition
Cervical Cancer
Precancerous Condition

Study Type: Observational
Official Title: Genomics Approach to Id Novel Targets & Markers for Early Detection And Intervention In Cancer (Cervical)

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer [ Time Frame: Done at the completion of the study. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes [ Time Frame: Done at the completion of the study. ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2004
Study Completion Date: May 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601601

Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Study Chair: Sylvia Lam British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00601601     History of Changes
Other Study ID Numbers: CDR0000581302, R01CA103830, BCCR-H04-60112, BCCR-RO4-0112
Study First Received: January 25, 2008
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

Keywords provided by British Columbia Cancer Agency:
stage 0 cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Carcinoma in Situ
Uterine Cervical Neoplasms
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014