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


N/A
19 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Outcome Time Frame:

Done at the completion of the study.

Safety Issue:

No

Principal Investigator

Sylvia Lam

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

United States: Federal Government

Study ID:

CDR0000581302

NCT ID:

NCT00601601

Start Date:

December 2004

Completion Date:

May 2011

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • stage 0 cervical cancer
  • cervical intraepithelial neoplasia grade 1
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Carcinoma in Situ
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia

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