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:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00805688
First received: December 5, 2008
Last updated: March 20, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2014 (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:
- Patients must have histologically or cytologically confirmed cancer of the pancreas.
- Patients must have inoperable locally advanced or metastatic disease.
- Patients could be on treatment, or being planned for chemotherapy treatment.
- Age 18 years of age or older
- ECOG performance status 0-3
- Ability to give consent in either English or Spanish
Exclusion Criteria:
- Any condition (including unwillingness) that would impair the patient's ability to utilize the IVR system
- Any recent surgical procedures (within 14 days, excluding biopsy, port-a-cath or picc line placement)
Contacts and Locations
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: | March 20, 2013 |
| 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 May 16, 2013