- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00601601
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)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer
Tidsram: Done at the completion of the study.
|
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
Tidsram: Done at the completion of the study.
|
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
Tidsram: Done at the completion of the study.
|
Done at the completion of the study.
|
Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes
Tidsram: Done at the completion of the study.
|
Done at the completion of the study.
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Sylvia Lam, British Columbia Cancer Agency
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDR0000581302
- R01CA103830 (U.S.S. NIH-anslag/kontrakt)
- BCCR-H04-60112
- BCCR-RO4-0112
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