- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Hvad måler undersøgelsen?
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.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Sylvia Lam, British Columbia Cancer Agency
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000581302
- R01CA103830 (U.S. NIH-bevilling/kontrakt)
- BCCR-H04-60112
- BCCR-RO4-0112
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Kliniske forsøg med Livmoderhalskræft
-
Xin Jiang, MDUkendt
-
Gangnam Severance HospitalAfsluttetAnterior Cervical Discectomy and Fusion (ACDF) kirurgiKorea, Republikken
-
University of ArkansasAfsluttetAnterior Cervical Discectomy and Fusion (ACDF)Forenede Stater
-
Cleveland Clinic Akron GeneralRekrutteringSmerte | Overfladisk Cervical Plexus BlockForenede Stater
-
AxioMed Spine CorporationUkendtSymptomatisk Cervical Degenerative Disc Disease (DDD) Fra C3-C7Tyskland, Schweiz
-
Qilu Pharmaceutical Co., Ltd.RekrutteringMETASTATISK CERVICAL CANCERKina
-
Orthofix Inc.AfsluttetDegenerativ diskussygdom | Vertebralt Cervical Fusion SyndromeForenede Stater
-
Istanbul Medeniyet UniversityAktiv, ikke rekrutterendeDiafragmatisk lammelse | Frenisk nervelammelse | Anterior suprascapular nerveblok | Overfladisk Cervical Plexus BlockKalkun
-
Antiva BiosciencesAfsluttetLivmoderhalskræft | Human Papilloma Virus | HSIL, højgradige pladeepitellæsioner | Cervikal dysplasi | HSIL af Cervix | Højgradig cervikal intraepitelial neoplasi | HIV negativ | CIN - Cervical Intraepithelial Neoplasia | Cervikal neoplasmaSydafrika