Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer
The goal of this clinical research study is to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer. Researchers will study the possible reason for these symptoms by drawing blood samples and comparing the test results to the symptoms you experience. The study will also use a special telephone system for measuring the symptoms of participants during and after therapy. Your level of physical activity will also be studied using a pedometer and study diary.
Procedure: Blood Draws
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Feasibility Study for Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer|
- Patient Reported Symptom Severity and Interference [ Time Frame: Weekly for 8 cycles of chemotherapy, followed by twice a month for 14 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood drawn (around 3½ tablespoons) before treatment starts to measure cytokines (biomarkers) and DNA.
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Questionnaires + Blood Draw + Pedometer used to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer.
Questionnaires including symptom review (MDSAI-GI) via personal or telephone interviews (interactive voice response telephone system - IVRS)
Other Name: surveyProcedure: Blood Draws
Blood sample (3½ tbs.)to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) before treatment starts.Device: Pedometer
Worn daily to measure physical activity.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00805688
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Xin Shelley Wang, MD, MPH||M.D. Anderson Cancer Center|