Pediatric CancersNCT00591539
Carotid Artery Disease in Childhood Cancer Survivors
An observational study of Pediatric Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if long-term survivors of childhood head or neck cancer, who received radiation therapy as part of the overall treatment plan, are at increased risk of thickening or blockage of the carotid arteries (the major blood vessels in the neck). Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric Cancers
- What is being tested?
- Carotid Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2010
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Long-term survivors of pediatric cancers who received radiation therapy to the neck as part of their treatment at M.D. Anderson Cancer Center.
Who may be able to join
- Subjects must have been less than 21 years of age at time of initial diagnosis.
- Patients treated at M.D. Anderson Cancer Center for any malignancy (including primary CNS tumors) that required unilateral radiation therapy to the head and neck area and involving the ipsilateral carotid artery as part of the overall treatment plan.
- Patients must be at least 5 years status post completion of therapy.
- Must be English speaking, or able to consent through an approved medical language translator.
- A written informed consent from the patient and/or the patient's legally authorized guardian must be obtained from all patients.
Who cannot join
- Leukemia patients receiving craniospinal irradiation
- Non-English speaking subjects for which no appropriate medical translator is available
- Patients who received head/neck radiation involving both carotid arteries will not be eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carotid Artery Disease in Long-Term Survivors of Childhood Cancer
The goal of this clinical research study is to find out if long-term survivors of childhood head or neck cancer, who received radiation therapy as part of the overall treatment plan, are at increased risk of thickening or blockage of the carotid arteries (the major blood vessels in the neck).
Researchers also want to find out if other medical conditions, such as high blood sugar, high blood cholesterol, or history of tobacco use may contribute to the thickening or blockage of the carotid arteries.
Read the detailed description
Some research shows that survivors of adult head or neck cancer, who received radiation therapy, are at increased risk for thickening or blockage of the carotid arteries, which may increase the risk for other medical conditions, such as stroke. Researchers want to learn about the possible risks of thickening or blockage of the carotid arteries in survivors of childhood head or neck cancer.
If you agree to take part in this study, researchers will see if there are any possible effects (thickening or blockage) of radiation therapy on your carotid arteries. This will be done by examining the test results from routine testing (mentioned below) that is normally done for your standard long-term follow-up care of the disease. These routine tests would be performed even if you were not in this research study.
During your long-term follow-up clinic appointment, you will have a physical exam and an ultrasound test (performed at the Cardiology Clinic) of the carotid arteries. A carotid ultrasound is a test that uses sound waves to look at the blood vessels in the neck. Blood will be drawn (about 2-3 teaspoons) for laboratory tests, including blood sugar level, blood cholesterol level, blood triglyceride level, thyroid hormone level, and blood levels of certain proteins (C-reactive protein and brain natriuretic peptide).
If any of the tests show any thickening or blockage of the carotid arteries or other medical problems, such as high blood sugar, your study doctor will discuss the test results, treatment options, and/or a follow-up plan with you.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Pediatric Cancers
- Being tested
- Carotid Ultrasound
- Keywords
- Carotid Artery Disease, Intima-Media Thickening, Carotid Ultrasound, Pediatric Cancer Survivors, Cancer Survivors, Head or Neck Cancer, Radiation Therapy
- Medical subject headings
- Carotid Artery Diseases, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid UltrasoundProcedure or surgery
Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Ultrasound | Carotid Ultrasound: Irradiated and non-irradiated sides of the neck in long-term survivors of pediatric cancers who received unilateral radiation therapy involving the carotid artery as part of their treatment Receives: Procedure: Carotid Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with Carotid intima-media thickening (IMT)
Measured: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
Secondary outcomes (1)
Patients with Carotid artery stenosis (CAS)
Measured: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Slow Accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancersStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winston Huh, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591539
- Sponsor's protocol ID
- 2006-0487
- Status last verified
- Jul 2012
- First submitted
- 28 Dec 2007
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Disease in Long-Term Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT00591539
- Acronym / sponsor ID
- 2006-0487
- Conditions
- Pediatric Cancers
- Keywords
- Carotid Artery Disease, Intima-Media Thickening, Carotid Ultrasound, Pediatric Cancer Survivors, Cancer Survivors, Head or Neck Cancer, Radiation Therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow Accrual.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Jan 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 find out if long-term survivors of childhood head or neck cancer, who received radiation therapy as part of the overall treatment plan, are at increased risk of thickening or blockage of the carotid arteries (the major blood vessels in the neck).
Researchers also want to find out if other medical conditions, such as high blood sugar, high blood cholesterol, or history of tobacco use may contribute to the thickening or blockage of the carotid arteries.
Detailed description
Some research shows that survivors of adult head or neck cancer, who received radiation therapy, are at increased risk for thickening or blockage of the carotid arteries, which may increase the risk for other medical conditions, such as stroke. Researchers want to learn about the possible risks of thickening or blockage of the carotid arteries in survivors of childhood head or neck cancer.
If you agree to take part in this study, researchers will see if there are any possible effects (thickening or blockage) of radiation therapy on your carotid arteries. This will be done by examining the test results from routine testing (mentioned below) that is normally done for your standard long-term follow-up care of the disease. These routine tests would be performed even if you were not in this research study.
During your long-term follow-up clinic appointment, you will have a physical exam and an ultrasound test (performed at the Cardiology Clinic) of the carotid arteries. A carotid ultrasound is a test that uses sound waves to look at the blood vessels in the neck. Blood will be drawn (about 2-3 teaspoons) for laboratory tests, including blood sugar level, blood cholesterol level, blood triglyceride level, thyroid hormone level, and blood levels of certain proteins (C-reactive protein and brain natriuretic peptide).
If any of the tests show any thickening or blockage of the carotid arteries or other medical problems, such as high blood sugar, your study doctor will discuss the test results, treatment options, and/or a follow-up plan with you.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Ultrasound | – | Procedure: Carotid UltrasoundCarotid Ultrasound: Irradiated and non-irradiated sides of the neck in long-term survivors of pediatric cancers who received unilateral radiation therapy involving the carotid artery as part of their treatment |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Long-term survivors of pediatric cancers who received radiation therapy to the neck as part of their treatment at M.D. Anderson Cancer Center.
Key inclusion criteria (5 listed)
- Subjects must have been less than 21 years of age at time of initial diagnosis.
- Patients treated at M.D. Anderson Cancer Center for any malignancy (including primary CNS tumors) that required unilateral radiation therapy to the head and neck area and involving the ipsilateral carotid artery as part of the overall treatment plan.
- Patients must be at least 5 years status post completion of therapy.
- Must be English speaking, or able to consent through an approved medical language translator.
- A written informed consent from the patient and/or the patient's legally authorized guardian must be obtained from all patients.
Key exclusion criteria (3 listed)
- Leukemia patients receiving craniospinal irradiation
- Non-English speaking subjects for which no appropriate medical translator is available
- Patients who received head/neck radiation involving both carotid arteries will not be eligible.
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 |
|---|---|---|
| Carotid UltrasoundBilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck. | Procedure or surgery | Carotid Ultrasound |
Primary outcome
Patients with Carotid intima-media thickening (IMT)
Time frame: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
1 secondary outcome
Patients with Carotid artery stenosis (CAS)
Time frame: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
Results and safety
The study was stopped early (reason given: Slow Accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- UT MD Anderson Cancer CenterLink 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.
Winston Huh, 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 Pediatric Cancers, 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 3 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: stopped early, as of the sponsor's last update on 31 Jul 2012. 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 was stopped early (reason given: Slow Accrual.). Results are not available in the source record.
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?
Patients with Carotid intima-media thickening (IMT) (time frame: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.). 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 31 Jul 2012.