Thymectomy and Cardiothoracic SurgeryNCT00263120
Effects of Thymectomy During Cardiothoracic Surgery
An observational study of Thymectomy and Cardiothoracic Surgery, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The thymus is known to be the site of T cell development in humans. Due to its location in the chest in front of the heart, incidental thymecomy is commonly performed during cardiothoracic surgery, especially in infants and children, so that surgeons may gain access to the surgical field. Read more about this study
- Who is it for?
- Ages Up to 35 years
- Conditions the study is for
- Thymectomy and Cardiothoracic Surgery
- What is being tested?
- Pain Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: child and young adult subjects who have undergone surgery in early childhood for correction or repair related to congenital heart disease enrolled for the observational portion of this protocol only
Who may be able to join
- Age: birth to 35 years.
- Planning cardiac surgical procedure at UCLA Medical Center.
- For subjects with a history of prior cardiothoracic surgery: undergoing CT or MRI evaluation prior to reoperation.
Who cannot join
- Unable to travel to UCLA Medical Center for follow up blood tests (infants and young children in longitudinal study)
- Known thymus/immune deficiency disorder (i.e. DiGeorge Syndrome)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Adult Congenital Heart Disease Clinic
Los Angeles, California, 90095
About this study
The thymus is known to be the site of T cell development in humans. Due to its location in the chest in front of the heart, incidental thymecomy is commonly performed during cardiothoracic surgery, especially in infants and children, so that surgeons may gain access to the surgical field. This practice has been considered safe because it was thought that the thymus is inactive after birth. However, recent data using newly developed techniques has demonstrated that the thymus normally is active well into adulthood. In addition, in a previous study (UCLA IRB # 02-03-008-02) we have demonstrated alterations in lymphocyte (T cells) number in individuals who have undergone thymectomy in childhood but we do not know how immunity is affected. We plan to investigate if immune development or immune function later in life is affected by the loss of T cell production caused by thymectomy during cardiothoracic surgical procedures in childhood. At UCLA, a large number of patients are seen who have congenital heart disease and undergo surgical procedures for correction or repair and many children and adults are followed for many years after they have undergone surgical procedures. Subjects for study will be recruited from among these patients.
We propose a study which will examine the number and activity of lymphocytes obtained from blood samples from child and young adult subjects who have undergone surgery in early childhood. We will determine if these subjects have had complete thymectomy in the past using CT or MRI (obtained during routine care) or, for subjects who are having cardiothoracic surgery, by visualization of thymic tissue during the procedure. In addition we will give vaccination for a common viral illness (hepatitis A) and measure immune responses to it (from a blood sample). As part of this study, we will ask for medical information consisting of a history of congenital cardiac disease and other diagnoses (such as asthma), a history of infections and hospitalizations, and information about immunizations. We will also ask about a list of specific symptoms which will give us information about the function of the immune system.
- Conditions
- Thymectomy and Cardiothoracic Surgery
- Being tested
- Pain Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain QuestionnaireBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
immune dysfunction
Measured: late
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startMar 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thymectomy and Cardiothoracic SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Cross-sectional
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Halnon, MD, MS, University of California, Los Angeles
- Investigators
- Nancy J. Halnon, M.D., Principal investigator, Pediatric Cardiology, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263120
- Sponsor's protocol ID
- 2005-12-003Halnon
- Status last verified
- Aug 2016
- First submitted
- 5 Dec 2005
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Halnon NJ, Jamieson B, Plunkett M, Kitchen CM, Pham T, Krogstad P. Thymic function and impaired maintenance of peripheral T cell populations in children with congenital heart disease and surgical thymectomy. Pediatr Res. 2005 Jan;57(1):42-8. doi: 10.1203/01.PDR.0000147735.19342.DE. Epub 2004 Nov 5.
PubMed 15531736Halnon NJ, Cooper P, Chen DY, Boechat MI, Uittenbogaart CH. Immune dysregulation after cardiothoracic surgery and incidental thymectomy: maintenance of regulatory T cells despite impaired thymopoiesis. Clin Dev Immunol. 2011;2011:915864. doi: 10.1155/2011/915864. Epub 2011 Jul 6.
PubMed 21776289
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thymectomy During Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT00263120
- Acronym / sponsor ID
- 2005-12-003Halnon
- Conditions
- Thymectomy and Cardiothoracic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Dec 2005 (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 thymus is known to be the site of T cell development in humans. Due to its location in the chest in front of the heart, incidental thymecomy is commonly performed during cardiothoracic surgery, especially in infants and children, so that surgeons may gain access to the surgical field. This practice has been considered safe because it was thought that the thymus is inactive after birth. However, recent data using newly developed techniques has demonstrated that the thymus normally is active well into adulthood. In addition, in a previous study (UCLA IRB # 02-03-008-02) we have demonstrated alterations in lymphocyte (T cells) number in individuals who have undergone thymectomy in childhood but we do not know how immunity is affected. We plan to investigate if immune development or immune function later in life is affected by the loss of T cell production caused by thymectomy during cardiothoracic surgical procedures in childhood. At UCLA, a large number of patients are seen who have congenital heart disease and undergo surgical procedures for correction or repair and many children and adults are followed for many years after they have undergone surgical procedures. Subjects for study will be recruited from among these patients.
We propose a study which will examine the number and activity of lymphocytes obtained from blood samples from child and young adult subjects who have undergone surgery in early childhood. We will determine if these subjects have had complete thymectomy in the past using CT or MRI (obtained during routine care) or, for subjects who are having cardiothoracic surgery, by visualization of thymic tissue during the procedure. In addition we will give vaccination for a common viral illness (hepatitis A) and measure immune responses to it (from a blood sample). As part of this study, we will ask for medical information consisting of a history of congenital cardiac disease and other diagnoses (such as asthma), a history of infections and hospitalizations, and information about immunizations. We will also ask about a list of specific symptoms which will give us information about the function of the immune system.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- child and young adult subjects who have undergone surgery in early childhood for correction or repair related to congenital heart disease enrolled for the observational portion of this protocol only
Key inclusion criteria (3 listed)
- Age: birth to 35 years.
- Planning cardiac surgical procedure at UCLA Medical Center.
- For subjects with a history of prior cardiothoracic surgery: undergoing CT or MRI evaluation prior to reoperation.
Key exclusion criteria (2 listed)
- Unable to travel to UCLA Medical Center for follow up blood tests (infants and young children in longitudinal study)
- Known thymus/immune deficiency disorder (i.e. DiGeorge Syndrome)
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 |
|---|---|---|
| Pain Questionnaire | Behavioural | – |
Primary outcome
immune dysfunction
Time frame: late
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 24 Aug 2016.
- Results publication: PubMed 15531736Halnon NJ, Jamieson B, Plunkett M, Kitchen CM, Pham T, Krogstad P. Thymic function and impaired maintenance of peripheral T cell populations in children with congenital heart disease and surgical thymectomy. Pediatr Res. 2005 Jan;57(1):42-8. doi: 10.1203/01.PDR.0000147735.19342.DE. Epub 2004 Nov 5.
- Results publication: PubMed 21776289Halnon NJ, Cooper P, Chen DY, Boechat MI, Uittenbogaart CH. Immune dysregulation after cardiothoracic surgery and incidental thymectomy: maintenance of regulatory T cells despite impaired thymopoiesis. Clin Dev Immunol. 2011;2011:915864. doi: 10.1155/2011/915864. Epub 2011 Jul 6.
- Individual participant dataSharing planned: No
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.
Nancy J. Halnon, M.D. principal investigator
Pediatric Cardiology, UCLA
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 Thymectomy and Cardiothoracic Surgery, run by University of California, Los Angeles 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 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 24 Aug 2016. 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?
immune dysfunction (time frame: late). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263120, which also lists 2 linked publications.
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 24 Aug 2016.