- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00898742
Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Molecular Signatures of HNSCC in Response to Targeted Therapies
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how will patients respond to treatment.
PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- To identify 100 patients from the Head and Neck Tumor Tissue Repository and Clinical Database treated with cetuximab monotherapy or cetuximab-containing combination therapy as a standard of care for recurrent and/or metastatic head and neck squamous cell carcinoma at Vanderbilt University Medical Center.
- To assay the diversity of gene and protein expression patterns seen in these patients.
- To identify predictive patterns associated with treatment response and survival of these patients by correlating the laboratory data with clinical data.
OUTLINE: Tumor tissue specimens and clinical data are obtained from the Head and Neck Tumor Tissue Repository and Clinical Database protocol VU-VICC-HN-0356. Specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by DNA microarray, tissue microarray, reverse transcriptase-PCR, and mass spectroscopy.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
-
Nashville, Tennessee, Forenede Stater, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma
- Enrolled on the Head and Neck Tissue Repository and Clinical Database protocol VU-VICC-HN-0356
- Previously treated with cetuximab monotherapy or cetuximab-based combination therapy
- Sufficient biological material available for analysis
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
head and neck cancer patients
|
The lab has a candidate gene expression signature for the prediction of the cetuximab response.
It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
The lab has a candidate gene expression signature for the prediction of the cetuximab response.
It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
The lab has a candidate gene expression signature for the prediction of the cetuximab response.
It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Identification of 100 patients from the Head and Neck (H&N) Tumor Tissue Repository and Clinical Database treated with cetuximab or cetuximab-containing combination therapy as a standard of care
Tidsramme: approximately three years from enrollment of first patient
|
approximately three years from enrollment of first patient
|
Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients
Tidsramme: upon colleciton of final patient data
|
upon colleciton of final patient data
|
Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival
Tidsramme: upon collection of final patient data
|
upon collection of final patient data
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
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
- tilbagevendende metastatisk planehalskræft med okkult primær
- metastatisk pladecellekræft med okkult primært pladecellekræft
- stadium IV planocellulært karcinom i læben og mundhulen
- stadium IV verrucous carcinom i mundhulen
- tilbagevendende pladecellekarcinom i læben og mundhulen
- tilbagevendende verrucous carcinom i mundhulen
- stadium IV planocellulært karcinom i oropharynx
- tilbagevendende pladecellekarcinom i oropharynx
- stadium IV planocellulært karcinom i nasopharynx
- tilbagevendende pladecellekarcinom i nasopharynx
- stadium IV planocellulært karcinom i hypopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- stadium IV planocellulært karcinom i strubehovedet
- stadium IV verrucous carcinom i strubehovedet
- tilbagevendende pladecellekarcinom i strubehovedet
- tilbagevendende verrucous carcinom i strubehovedet
- stadium IV planocellulært karcinom i paranasale sinus og næsehulen
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
- tilbagevendende spytkirtelkræft
- stadium IV spytkirtelkræft
- spytkirtel planocellulært karcinom
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VICC HN 0715
- P30CA068485 (U.S. NIH-bevilling/kontrakt)
- VU-VICC-HN-0715
- VU-VICC-070668
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med DNA and tissue microarray analysis
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)Afsluttet
-
Assistance Publique - Hôpitaux de ParisIkke rekrutterer endnu