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Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00805688
Recruitment Status : Active, not recruiting
First Posted : December 10, 2008
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Pancreatic Cancer Behavioral: Questionnaires Procedure: Blood Draws Device: Pedometer

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
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
Actual Study Start Date : November 2008
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Symptom Study
Questionnaires + Blood Draw + Pedometer used to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer.
Behavioral: Questionnaires
Questionnaires including symptom review (MDSAI-GI) via personal or telephone interviews (interactive voice response telephone system - IVRS)
Other Name: survey
Procedure: 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.



Primary Outcome Measures :
  1. Patient Reported Symptom Severity and Interference [ Time Frame: Weekly for 8 cycles of chemotherapy, followed by twice a month for 14 months ]

Biospecimen Retention:   Samples With DNA
Blood drawn (around 3½ tablespoons) before treatment starts to measure cytokines (biomarkers) and DNA.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study participants will comprise 100 consecutive outpatients with metastatic disease being treated at the GI Medical Oncology clinic at M. D. Anderson.
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed cancer of the pancreas.
  2. Patients must have inoperable locally advanced or metastatic disease.
  3. Patients could be on treatment, or being planned for chemotherapy treatment.
  4. Age 18 years of age or older
  5. ECOG performance status 0-3
  6. Ability to give consent in either English or Spanish

Exclusion Criteria:

  1. Any condition (including unwillingness) that would impair the patient's ability to utilize the IVR system
  2. Any recent surgical procedures (within 14 days, excluding biopsy, port-a-cath or picc line placement)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805688


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Xin Shelley Wang, MD, MPH M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00805688     History of Changes
Other Study ID Numbers: 2008-0582
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Questionnaire
Pancreas
Pancreatic Cancer
Metastatic Disease
symptom outcomes
Biomarkers
Pedometer
MDASI-GI symptom assessment
interactive voice response telephone system
IVRS

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases