- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Done at the completion of the study.
|
Done at the completion of the study.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Sylvia Lam, British Columbia Cancer Agency
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000581302
- R01CA103830 (U.S. NIH-stipend/kontrakt)
- BCCR-H04-60112
- BCCR-RO4-0112
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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