Cancer SurvivorNCT02032121
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
A study testing Blood specimen and Echocardiography in people with Cancer Survivor and Pediatric Cancer, run by University of Miami at 1 site in United States.
Trial summary
Survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. The nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivor, Pediatric Cancer
- What is being tested?
- Blood specimen and Echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2015
- Phase
- Interventional
- 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 6 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 6-30 years of age
- 2 years from the completion of therapy for cancer
- free of active disease
Who cannot join
- <6 or > 30 years of age
- current cancer treatment or inside of 2 years post treatment
- Active disease/infection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, MIller School of Medicine
Miami, Florida, 33136
About this study
Survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. The nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as well as measure of blood vessel stiffness (both of which are predictive of early heart disease) in 100 pediatric cancer survivors and 100 control children. Characterization of vascular inflammation and stiffness in long-term survivors will allow for the development of future interventions to decrease inflammation through both pharmacologic and lifestyle modifications.
- Conditions
- Cancer Survivor, Pediatric Cancer
- Being tested
- Blood specimen, Echocardiography
- Keywords
- Cancer survivors, Long-term cancer survivor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood specimenProcedure or surgery
EchocardiographyProcedure or surgery
Also called Flow mediated vasodilation, Carotid intimal media thickness, Bone Mineral Density
| Study group | Role | What they receive |
|---|---|---|
| Intervention procedures | Experimental | All the procedures will be completed for every subject Receives: Procedure: Blood specimen; Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Inflammation
All study procedures to assess vascular inflammation will be assessed through specimen sample collection and through procedures such as (echocardiograph)
Measured: single time point at initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2007
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracie L. Miller, MD, University of Miami
- Investigators
- Tracie L Miller, MD, SM, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032121
- Sponsor's protocol ID
- 20070584
- Status last verified
- Sep 2015
- First submitted
- 8 Jan 2014
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
- ClinicalTrials.gov ID
- NCT02032121
- Acronym / sponsor ID
- 20070584
- Conditions
- Cancer Survivor, Pediatric Cancer
- Keywords
- Cancer survivors, Long-term cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Jan 2014 (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.
Survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. The nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as well as measure of blood vessel stiffness (both of which are predictive of early heart disease) in 100 pediatric cancer survivors and 100 control children. Characterization of vascular inflammation and stiffness in long-term survivors will allow for the development of future interventions to decrease inflammation through both pharmacologic and lifestyle modifications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention procedures | Experimental | Procedure: Blood specimen, Procedure: EchocardiographyAll the procedures will be completed for every subject |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 6-30 years of age
- 2 years from the completion of therapy for cancer
- free of active disease
Key exclusion criteria (3 listed)
- <6 or > 30 years of age
- current cancer treatment or inside of 2 years post treatment
- Active disease/infection
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 |
|---|---|---|
| Blood specimen | Procedure or surgery | Intervention procedures |
| EchocardiographyAlso: Flow mediated vasodilation, Carotid intimal media thickness, Bone Mineral Density | Procedure or surgery | Intervention procedures |
Primary outcome
Vascular Inflammation
Time frame: single time point at initial visit
All study procedures to assess vascular inflammation will be assessed through specimen sample collection and through procedures such as (echocardiograph)
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 9 Sep 2015.
Related trials for Cancer Survivor
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
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.
Tracie L Miller, MD, SM principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood specimen and Echocardiography in people with Cancer Survivor and Pediatric Cancer, run by University of Miami 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 3 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: finished, as of the sponsor's last update on 9 Sep 2015. 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?
Vascular Inflammation (time frame: single time point at initial visit). 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 9 Sep 2015.