- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00897832
Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer
Developing Predictive Markers of Therapeutic Response in Pancreatic Cancer
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- To determine if a method of extracting and identifying biomarkers (i.e., secreted cytokines and growth factors) from tissues of the quantity obtained from typical biopsy can now be applied in the setting of pancreatic cancer
- To correlate pre-treatment biomarkers with recurrence, overall survival, and tumor response to radiotherapy and chemotherapy in patients with pancreatic cancer.
OUTLINE: Tumor tissue specimens are obtained from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core and analyzed for biomarkers (e.g., integrity of DNA repair pathways as analyzed by Rad51 and phosphorylated DNA-PK foci formation). The biomarkers are correlated with clinical outcomes (recurrence, overall survival, and tumor response to treatment).
Patients are followed for recurrence, relapse, and death from disease.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, Forente stater, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, Forente stater, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion criteria
- Diagnosis of pancreatic cancer
- Excess tissue collected at the time of routine surgery for pancreatic cancer must be available for analysis
Exclusion criteria
- None known
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
pancreatic cancer
Patients with pancreatic cancer
|
Using material that is already being acquired as a component of clinical care (only that which is excess after routine clinical care), it will be determined if pre-treatment markers can be used to correlate with clinical outcomes of survival and recurrence.
Examples of such markers include studying if the integrity of DNA repair pathway in pancreatic cancers, analyzed by Rad51 and phosphorylated DNA-PK foci formation, correlates with tumor response to radiotherapy, chemotherapy, and overall survival.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determination if a method of extracting and identifying biomarkers from tissues of the quantity obtained from typical biopsy can be applied in the setting of pancreatic cancer
Tidsramme: 1 year following final patient data
|
1 year following final patient data
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: A. Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
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
- VICC GI 0666
- P30CA068485 (U.S. NIH-stipend/kontrakt)
- VU-VICC-GI-0666
- VU-VICC-061225
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