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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00805688
First received: December 5, 2008
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 Intervention
Pancreatic Cancer
Behavioral: Questionnaires
Procedure: Blood Draws
Device: Pedometer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805688

Locations
United States, Texas
UT 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 UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00805688     History of Changes
Other Study ID Numbers: 2008-0582
Study First Received: December 5, 2008
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014