TumorNCT00777751
Radiation Therapy and Cardiac Enzymes
An observational study of Tumor, 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 if the radiation that you are receiving will result in an increase in certain proteins produced by the heart called cardiac biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2008to 21 Nov 2016
- 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: Patients with tumors in the chest in close proximity to the heart, including histologically proven primary lung cancer, esophageal cancer, or thymoma, to be treated with single modality RT.
Who may be able to join
- A total of thirty patients will be prospectively enrolled in this study. Patients with tumors in the chest including histologically proven primary lung cancer, esophageal cancer, thymoma or mesothelioma to be treated with RT with or without concurrent chemotherapy to a final dose of >/=45 Gy will be included in this study.
- Patients with tumors in close proximity to the heart where the treating radiation oncologist anticipates the mean cardiac dose will exceed 20Gy.
- All patients must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
- Age >/= 18
- Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]. For women of childbearing potential, a blood pregnancy test must be performed within 72 hours prior to the start of protocol treatment.
Who cannot join
- Patients who receive 5-fluorouracil or adriamycin as part of their chemotherapy regimen.
- Patients with recent myocardial infarction in the past month, decompensated heart failure or myocarditis/pericarditis in the past month
- Patients with renal failure indicated by a serum creatinine level of >/= 2.0.
- Patients in the intensive care unite (ICU).
- Patients with systemic sepsis.
- Patients with acute pulmonary embolism in the past month.
- Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child.
- Inability to obtain histologic proof of malignancy.
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: Radiation Therapy and Cardiac Biomarkers
The goal of this clinical research study is to learn if the radiation that you are receiving will result in an increase in certain proteins produced by the heart called cardiac biomarkers.
Read the detailed description
Cardiac Biomarkers:
Cardiac biomarkers are proteins made by the heart. When cardiac biomarkers are above normal levels, there may be damage to the heart. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy. How cardiac biomarkers can play a role in predicting future heart problems during radiation therapy will also be studied.
Study Tests:
If you agree to take part in this study, blood (about 1 teaspoon) will be drawn to measure certain cardiac biomarkers up to 2 days before radiation therapy, following the first treatment of radiation, within 2 days of finishing radiation therapy, and about 1 to 2 months after completion of radiation therapy. Once the blood testing is completed, any leftover blood samples will be destroyed.
You will also have electrocardiograms (ECGs -- tests that measure the electrical activity of the heart) at the same time points as the blood draws.
Length of Study:
You will be off study after the last blood draw and ECG.
This is an investigational study. Up to 30 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Tumor
- Keywords
- Chest Tumor, Heart, Lung Cancer, Esophageal Cancer, Thymoma, Radiation dose to the heart, Cardiac Enzymes, Cardiac Biomarkers, Radiation Therapy, RT, Electrocardiograms, ECG
- Medical subject headings
- Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Thymoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevation in cardiac biomarkers by measuring cardiac troponins (troponin T and troponin I), BNP, and CK-MB.
Measured: 4 Time Points: within 1 week prior to radiation therapy (RT), within 1-3 days of RT completion, and at 1 and 3 months after completion of RT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study start6 Oct 2008
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Grosshans, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777751
- Sponsor's protocol ID
- 2007-0489
- Status last verified
- Jan 2018
- First submitted
- 21 Oct 2008
- Last updated
- 10 Jan 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 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy and Cardiac Biomarkers
- ClinicalTrials.gov ID
- NCT00777751
- Acronym / sponsor ID
- 2007-0489
- Conditions
- Tumor
- Keywords
- Chest Tumor, Heart, Lung Cancer, Esophageal Cancer, Thymoma, Radiation dose to the heart, Cardiac Enzymes, Cardiac Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Oct 2008 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 22 Oct 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 if the radiation that you are receiving will result in an increase in certain proteins produced by the heart called cardiac biomarkers.
Detailed description
Cardiac Biomarkers:
Cardiac biomarkers are proteins made by the heart. When cardiac biomarkers are above normal levels, there may be damage to the heart. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy. How cardiac biomarkers can play a role in predicting future heart problems during radiation therapy will also be studied.
Study Tests:
If you agree to take part in this study, blood (about 1 teaspoon) will be drawn to measure certain cardiac biomarkers up to 2 days before radiation therapy, following the first treatment of radiation, within 2 days of finishing radiation therapy, and about 1 to 2 months after completion of radiation therapy. Once the blood testing is completed, any leftover blood samples will be destroyed.
You will also have electrocardiograms (ECGs -- tests that measure the electrical activity of the heart) at the same time points as the blood draws.
Length of Study:
You will be off study after the last blood draw and ECG.
This is an investigational study. Up to 30 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tumors in the chest in close proximity to the heart, including histologically proven primary lung cancer, esophageal cancer, or thymoma, to be treated with single modality RT.
Key inclusion criteria (5 listed)
- A total of thirty patients will be prospectively enrolled in this study. Patients with tumors in the chest including histologically proven primary lung cancer, esophageal cancer, thymoma or mesothelioma to be treated with RT with or without concurrent chemotherapy to a final dose of >/=45 Gy will be included in this study.
- Patients with tumors in close proximity to the heart where the treating radiation oncologist anticipates the mean cardiac dose will exceed 20Gy.
- All patients must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
- Age >/= 18
- Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]. For women of childbearing potential, a blood pregnancy test must be performed within 72 hours prior to the start of protocol treatment.
Key exclusion criteria (8 listed)
- Patients who receive 5-fluorouracil or adriamycin as part of their chemotherapy regimen.
- Patients with recent myocardial infarction in the past month, decompensated heart failure or myocarditis/pericarditis in the past month
- Patients with renal failure indicated by a serum creatinine level of >/= 2.0.
- Patients in the intensive care unite (ICU).
- Patients with systemic sepsis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elevation in cardiac biomarkers by measuring cardiac troponins (troponin T and troponin I), BNP, and CK-MB.
Time frame: 4 Time Points: within 1 week prior to radiation therapy (RT), within 1-3 days of RT completion, and at 1 and 3 months after completion of RT.
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 10 Jan 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
David Grosshans, MD 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 Tumor, 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 5 inclusion and 8 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 10 Jan 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?
Elevation in cardiac biomarkers by measuring cardiac troponins (troponin T and troponin I), BNP, and CK-MB. (time frame: 4 Time Points: within 1 week prior to radiation therapy (RT), within 1-3 days of RT completion, and at 1 and 3 months after completion of RT.). 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 10 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.