Pancreatic CancerNCT00805688
Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer
An observational study of Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Questionnaires, Blood Draws and Pedometer
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2008to 27 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Feasibility Study for 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.
Read the detailed description
Researchers want to try to improve patient care for advanced pancreatic cancer by looking at how some symptoms create a great burden on daily life. They also want to find out which "markers" in the blood. Biomarkers are substances found in the blood, such as cytokines, certain proteins, and DNA changes. These biomarkers may help doctors predict "symptom burden" during therapy.
Researchers would also like to collect data about your physical function as part of this study. If you agree to wear a pedometer, you will wear the pedometer every day for a month during your waking hours. The pedometer used in the study is a small box that weighs less than an ounce and is smaller than a deck of playing cards. It is used to measure the number of steps you take during the day. Researchers will help you set the pedometer and show you how to use it. You will also keep a diary to record your use of the pedometer during this month. Researchers will meet with you during your clinic visits for chemotherapy at 2 weeks and 4 weeks to collect the data.
If you agree to take part in this study, you will have the following 4 types of study procedures performed:
Questionnaire:
Before chemotherapy that is scheduled by GI Medical Oncology Clinic starts, you will be asked to complete a questionnaire during a visit to the clinic. The questionnaire will measures physical and emotional symptoms. It should take about 5 minutes to finish. During this visit, the research staff will also teach you how to use the telephone system for measuring symptoms. You will tell the research staff the most convenient times for the telephone calls each week and the system will be set up to call you at that time.
Blood Draws:
Before you begin your chemotherapy treatments, you will have a sample of blood drawn (around 3½ tablespoons). The sample of blood will be used to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) in your blood before treatment starts. These cytokines may be related to symptoms experienced while having treatment for cancer.
You will have about 2½ tablespoons of blood drawn again when you complete first and second cycle of chemotherapy, and then at 2 months and 4 months after the start date of chemotherapy. Each blood sample will be drawn during your routine blood draw for continuing chemotherapy.
Symptoms Review:
You will have a MDASI-GI symptom assessment face to face, by regular mail, or through the phone calls. These will be used to measure symptom burden over time of the treatment and after treatment. The assessments will be done weekly for up to 4 months and then twice a month for up to an additional 14 months.
If your assessment is done by phone, it may be done by a study staff member or by using an interactive voice response telephone system (IVRS). During the study, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms get in the way of your daily life. The information collected by these calls is only being used for this research study. This phone call should take about 5 minutes to complete.
This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Pancreatic Cancer
- Being tested
- Questionnaires, Blood Draws, Pedometer
- Keywords
- Questionnaire, Pancreas, Pancreatic Cancer, Metastatic Disease, symptom outcomes, Biomarkers, Pedometer, MDASI-GI symptom assessment, interactive voice response telephone system, IVRS
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called survey
Questionnaires including symptom review (MDSAI-GI) via personal or telephone interviews (interactive voice response telephone system - IVRS)
Blood DrawsProcedure or surgery
Blood sample (3½ tbs.)to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) before treatment starts.
PedometerDevice
Worn daily to measure physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Symptom Study | Questionnaires + Blood Draw + Pedometer used to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer. Receives: Behavioral: Questionnaires; Procedure: Blood Draws; Device: Pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Symptom Severity and Interference
Measured: Weekly for 8 cycles of chemotherapy, followed by twice a month for 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study start12 Nov 2008
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Shelley Wang, MD, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805688
- Sponsor's protocol ID
- 2008-0582
- Status last verified
- Mar 2018
- First submitted
- 5 Dec 2008
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00805688
- Acronym / sponsor ID
- 2008-0582
- Conditions
- Pancreatic Cancer
- Keywords
- Questionnaire, Pancreas, Pancreatic Cancer, Metastatic Disease, symptom outcomes, Biomarkers, Pedometer, MDASI-GI symptom assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Nov 2008 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Researchers want to try to improve patient care for advanced pancreatic cancer by looking at how some symptoms create a great burden on daily life. They also want to find out which "markers" in the blood. Biomarkers are substances found in the blood, such as cytokines, certain proteins, and DNA changes. These biomarkers may help doctors predict "symptom burden" during therapy.
Researchers would also like to collect data about your physical function as part of this study. If you agree to wear a pedometer, you will wear the pedometer every day for a month during your waking hours. The pedometer used in the study is a small box that weighs less than an ounce and is smaller than a deck of playing cards. It is used to measure the number of steps you take during the day. Researchers will help you set the pedometer and show you how to use it. You will also keep a diary to record your use of the pedometer during this month. Researchers will meet with you during your clinic visits for chemotherapy at 2 weeks and 4 weeks to collect the data.
If you agree to take part in this study, you will have the following 4 types of study procedures performed:
Questionnaire:
Before chemotherapy that is scheduled by GI Medical Oncology Clinic starts, you will be asked to complete a questionnaire during a visit to the clinic. The questionnaire will measures physical and emotional symptoms. It should take about 5 minutes to finish. During this visit, the research staff will also teach you how to use the telephone system for measuring symptoms. You will tell the research staff the most convenient times for the telephone calls each week and the system will be set up to call you at that time.
Blood Draws:
Before you begin your chemotherapy treatments, you will have a sample of blood drawn (around 3½ tablespoons). The sample of blood will be used to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) in your blood before treatment starts. These cytokines may be related to symptoms experienced while having treatment for cancer.
You will have about 2½ tablespoons of blood drawn again when you complete first and second cycle of chemotherapy, and then at 2 months and 4 months after the start date of chemotherapy. Each blood sample will be drawn during your routine blood draw for continuing chemotherapy.
Symptoms Review:
You will have a MDASI-GI symptom assessment face to face, by regular mail, or through the phone calls. These will be used to measure symptom burden over time of the treatment and after treatment. The assessments will be done weekly for up to 4 months and then twice a month for up to an additional 14 months.
If your assessment is done by phone, it may be done by a study staff member or by using an interactive voice response telephone system (IVRS). During the study, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms get in the way of your daily life. The information collected by these calls is only being used for this research study. This phone call should take about 5 minutes to complete.
This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptom Study | – | Behavioral: Questionnaires, Procedure: Blood Draws, Device: PedometerQuestionnaires + Blood Draw + Pedometer used to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: surveyQuestionnaires including symptom review (MDSAI-GI) via personal or telephone interviews (interactive voice response telephone system - IVRS) | Behavioural | Symptom Study |
| Blood DrawsBlood sample (3½ tbs.)to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) before treatment starts. | Procedure or surgery | Symptom Study |
| PedometerWorn daily to measure physical activity. | Device | Symptom Study |
Primary outcome
Patient Reported Symptom Severity and Interference
Time frame: Weekly for 8 cycles of chemotherapy, followed by twice a month for 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
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RecruitingPhase 1
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RecruitingPhase 3
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Shelley Wang, MD, MPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Symptom Severity and Interference (time frame: Weekly for 8 cycles of chemotherapy, followed by twice a month for 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.