- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
Nashville, Tennessee, Förenta staterna, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
-
Nashville, Tennessee, Förenta staterna, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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
Tidsram: 1 year following final patient data
|
1 year following final patient data
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: A. Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
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
- VICC GI 0666
- P30CA068485 (U.S.S. NIH-anslag/kontrakt)
- VU-VICC-GI-0666
- VU-VICC-061225
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