Malignant Neoplasm of ThyroidNCT02645786
Thyrotropin Over-suppression and Heart
An observational study of Malignant Neoplasm of Thyroid and Heart Diseases, run by Chuncheon Sacred Heart Hospital.
Trial summary
The investigators evaluated the cardiac effects of Thyroid-stimulating hormone (TSH) over-suppression in women with differentiated thyroid cancer (DTC) frequently encountered during suppression therapy. Read more about this study
- Who is it for?
- Ages 32 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm of Thyroid, Heart Diseases, Thyrotoxicosis on Thyroxine Therapy
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Apr 2014
- 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 32 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female differentiated thyroid cancer patients who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. Finally, 14 DTC patients were enrolled and studied from September 2009 to March 2010. As each patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. All subjects who met the enrollment criteria took an electrocardiogram to rule out arrhythmias.
Who may be able to join
- thyroid cancer group
- age less than 45 years old when receiving total or near-total thyroidectomy,
- serum level of TSH<0.1 mU/L in the intermediate -risk or TSH<0.3 mU/L in the low recurrence-risk group over 2 years before study entry,
- receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and
- no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy.
- control group
Show all 10Show fewer
- the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2),
- within the reference range of serum TSH (0.3-4.6 mU/L),
- no history of structural heart disease, arrhythmia, or cardiac symptoms,
- no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.
Who cannot join
- who had arrhythmia in electrography or history of cardiac disease
About this study
Official title: Cardiac Effects of Thyrotropin Over-Suppression With Levothyroxine in Young Women With Differentiated Thyroid Cancer
The investigators evaluated the cardiac effects of Thyroid-stimulating hormone (TSH) over-suppression in women with differentiated thyroid cancer (DTC) frequently encountered during suppression therapy.
Read the detailed description
The aim of this study was to evaluate the cardiac effects of TSH over-suppression in women with DTC during TSH suppressive therapy for 5 to 9 years relative to their risk of recurrence.
Methods
- Patients From chart review, the investigators selected 96 female differentiated thyroid cancer patients who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. Majority of papillary thyroid cancer tends to present between 30 and 50 years old and their risk of recurrence is low or intermediate. Menopause also might affect on the cardiovascular risk factors in women. According to guidelines, the dose of thyroxine would be reduced after 10 years of thyroidectomy in DTC patients. Therefore, additional enrollment criteria were as follows: 1) age less than 45 years old when receiving total or near-total thyroidectomy, 2) serum level of TSH<0.1 mU/L in the intermediate -risk or TSH<0.3 mU/L in the low recurrence-risk group, over 2 years before study entry, 3) receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and 4) no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy. Of the 17 patients who met the criteria, three patients did not consent to this study. Candidates who satisfied all the enrollment criteria took an electrocardiogram to rule out patients with arrhythmia. Finally, 14 DTC patients were enrolled and studied from September 2009 to March 2010. As each patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria: 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension. All subjects who met the enrollment criteria took an electrocardiogram to rule out arrhythmias. Control subjects were recruited and tested from January 2010 to July 2011. All participants provided written informed consent.
- Assays On the examination day, all participants were prohibited from smoking and consuming caffeine. After a light breakfast and medication, including levo-thyroxine (LT4) in cancer patients, participants visited the hospital before 9 AM. The investigators evaluated the comorbid conditions of the participants. Body weight and height were measured while the participants wore light clothing without shoes. The body mass index (BMI) was calculated as the weight in kilograms divided by the height in meters squared. Their blood pressure was taken after a 10 minute rest period. Subsequently, each subject underwent a 2-dimensional echocardiogram carried out by one examiner. After the cardiac work-up, blood samples were drawn to test of thyroid function. Blood samples were collected in pre-chilled tubes containing EDTA, immediately placed on ice, and promptly centrifuged at 4°C. After separation, plasma was stored at -80°C for the N-terminal pro-brain natriuretic peptide (NT-pro-BNP). Serum thyroid function tests were performed by a chemiluminescent immunoassay (UNICELL DXI800, Beckman Coulter, USA). Serum TSH (reference value: 0.3-4.6 mU/L, detection limit: 0.0025 mU/L), free T4 (reference value: 7.0-20.0 pmol/L), and free T3 (reference value: 4.0-5.9 pmol/L) were measured. Plasma NT-pro-BNP measurements were done using chemiluminescent immunoassay method (Roche E170, Roche diagnostics, Germany)
- Echocardiography
Comprehensive transthoracic echocardiography was performed using commercially available equipment (IE33, Philips Medical System, Andover, Massachusetts). Standard 2-dimensional measurements were obtained as recommended by the American Society of Echocardiography (ASE) in the left lateral position. Left atrial volume index was measured by the biplane area-length method. Left ventricular (LV) mass was calculated using the following equation: LV mass = 0.8 (1.04 { [LVIDd + PWTd + IVSd]3 - [LVIDd]3 } )+ 0.6, where LVID is LV end-diastolic dimension, PWT is posterior wall thickness, IVS is interventricular septal wall thickness, and d is diastole. Tissue Doppler-derived early diastolic mitral annular velocity (e') and late diastolic mitral annular velocity (a') were measured from the septal corner of the mitral annulus in the apical 4-chamber view. To evaluate the global longitudinal strain (GLS) of the left ventricle, echocardiographic images were obtained at the apical 4-chambers view and the strain was analyzed based on routine DICOM (Digital Imaging and Communications in Medicine) data sets using software (2D Cardiac Performance Analysis, TomTec, Munich, Germany). A region of interest was manually placed on the endocardial and epicardial borders. The echocardiographic data were gathered and analyzed by 2 experienced echocardiographers who were unaware of any corresponding clinical data.
Statistical analysis Data were reported as means and standard deviation (SD). For the comparison of means between groups, we used the Mann-Whitney test because the sample size was small (n=14 for each group).
All P values calculated are two-tailed and considered significant at P < 0.05. All statistical analysis was performed using SPSS 20.0 software (SPSS Inc, Chicago, USA).
- Keywords
- thyroid neoplasms, heart, thyroxine, thyrotoxicosis
- Medical subject headings
- Thyroid Neoplasms, Heart Diseases, Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Differentiated thyroid cancer group: who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. 1) age less than 45 years old when receiving total or near-total thyroidectomy, 2) serum level of TSH<0.1 mU/L in the intermediate recurrence-risk or TSH<0.3 mU/L in the low recurrence-risk group13, 14 over 2 years before study entry, 3) receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and 4) no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy. | |
| Control | Control group As each DTC patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of cardiac fucntion and structure between groups
In DTC group, the investiagtors measured cardiac function and structure by echocardiography at 2009 (receiving TSH suppressive therapy for 5 to 9 years after thyroidectomy). As each DTC patient was enrolled, control subjects were selected from persons who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria: 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.The cardiac function and structure were evaluated by echocardiography at 2010.
Measured: measure cardiac function and struture at 2009 in case (DTC group) and at 2010 in control group
Secondary outcomes (3)
comparison of heart rate between groups
In DTC group, the investiagtors measured heart rate at 2009 (receiving TSH suppressive therapy for 5 to 9 years after thyroidectomy). As each DTC patient was enrolled, control subjects were selected from persons who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria: 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.Heart rate were evaluated at 2010 in control group.
Measured: measure heart rate at 2009 in case (DTC group) and at 2010 in control group.
comparison of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) between groups
In DTC group, the investiagtors measured NT-Pro-BNP at 2009 (receiving TSH suppressive therapy for 5 to 9 years after thyroidectomy). As each DTC patient was enrolled, control subjects were selected from persons who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria: 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.NT-Pro-BNP was evaluated at 2010 in control group.
Measured: measure NT-pro-BNP at 2009 in DTC group and at 2010 in control group
thyroid function test (TSH, free T4, free T3)
In DTC group, the investiagtors measured thyroid function test at 2009 (receiving TSH suppressive therapy for 5 to 9 years after thyroidectomy). As each DTC patient was enrolled, control subjects were selected from persons who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria: 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.Thyroid function test was evaluated at 2010 in control group.
Measured: comparison of thyroid function at 2009 in case (DTC) and 2010 in control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startSep 2009
- Primary completionNov 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of ThyroidStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OHKHYUN RYU, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645786
- Sponsor's protocol ID
- 2009-19
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We have no plan to share the data with other investigator.
Publications
Hong KS, Son JW, Ryu OH, Choi MG, Hong JY, Lee SJ. Cardiac Effects of Thyrotropin Oversuppression with Levothyroxine in Young Women with Differentiated Thyroid Cancer. Int J Endocrinol. 2016;2016:9846790. doi: 10.1155/2016/9846790. Epub 2016 Jun 23.
PubMed 27418929
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Effects of Thyrotropin Over-Suppression With Levothyroxine in Young Women With Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT02645786
- Acronym / sponsor ID
- 2009-19
- Keywords
- thyroid neoplasms, heart, thyroxine, thyrotoxicosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Jan 2016 (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 investigators evaluated the cardiac effects of Thyroid-stimulating hormone (TSH) over-suppression in women with differentiated thyroid cancer (DTC) frequently encountered during suppression therapy.
Detailed description
The aim of this study was to evaluate the cardiac effects of TSH over-suppression in women with DTC during TSH suppressive therapy for 5 to 9 years relative to their risk of recurrence.
Methods
- Patients From chart review, the investigators selected 96 female differentiated thyroid cancer patients who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. Majority of papillary thyroid cancer tends to present between 30 and 50 years old and their risk of recurrence is low or intermediate. Menopause also might affect on the cardiovascular risk factors in women. According to guidelines, the dose of thyroxine would be reduced after 10 years of thyroidectomy in DTC patients. Therefore, additional enrollment criteria were as follows: 1) age less than 45 years old when receiving total or near-total thyroidectomy, 2) serum level of TSH<0.1 mU/L in the intermediate -risk or TSH<0.3 mU/L in the low recurrence-risk group, over 2 years before study entry, 3) receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and 4) no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy. Of the 17 patients who met the criteria, three patients did not consent to this study. Candidates who satisfied all the enrollment criteria took an electrocardiogram to rule out patients with arrhythmia. Finally, 14 DTC patients were enrolled and studied from September 2009 to March 2010. As each patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria: 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension. All subjects who met the enrollment criteria took an electrocardiogram to rule out arrhythmias. Control subjects were recruited and tested from January 2010 to July 2011. All participants provided written informed consent.
- Assays On the examination day, all participants were prohibited from smoking and consuming caffeine. After a light breakfast and medication, including levo-thyroxine (LT4) in cancer patients, participants visited the hospital before 9 AM. The investigators evaluated the comorbid conditions of the participants. Body weight and height were measured while the participants wore light clothing without shoes. The body mass index (BMI) was calculated as the weight in kilograms divided by the height in meters squared. Their blood pressure was taken after a 10 minute rest period. Subsequently, each subject underwent a 2-dimensional echocardiogram carried out by one examiner. After the cardiac work-up, blood samples were drawn to test of thyroid function. Blood samples were collected in pre-chilled tubes containing EDTA, immediately placed on ice, and promptly centrifuged at 4°C. After separation, plasma was stored at -80°C for the N-terminal pro-brain natriuretic peptide (NT-pro-BNP). Serum thyroid function tests were performed by a chemiluminescent immunoassay (UNICELL DXI800, Beckman Coulter, USA). Serum TSH (reference value: 0.3-4.6 mU/L, detection limit: 0.0025 mU/L), free T4 (reference value: 7.0-20.0 pmol/L), and free T3 (reference value: 4.0-5.9 pmol/L) were measured. Plasma NT-pro-BNP measurements were done using chemiluminescent immunoassay method (Roche E170, Roche diagnostics, Germany)
- Echocardiography
Comprehensive transthoracic echocardiography was performed using commercially available equipment (IE33, Philips Medical System, Andover, Massachusetts). Standard 2-dimensional measurements were obtained as recommended by the American Society of Echocardiography (ASE) in the left lateral position. Left atrial volume index was measured by the biplane area-length method. Left ventricular (LV) mass was calculated using the following equation: LV mass = 0.8 (1.04 { [LVIDd + PWTd + IVSd]3 - [LVIDd]3 } )+ 0.6, where LVID is LV end-diastolic dimension, PWT is posterior wall thickness, IVS is interventricular septal wall thickness, and d is diastole. Tissue Doppler-derived early diastolic mitral annular velocity (e') and late diastolic mitral annular velocity (a') were measured from the septal corner of the mitral annulus in the apical 4-chamber view. To evaluate the global longitudinal strain (GLS) of the left ventricle, echocardiographic images were obtained at the apical 4-chambers view and the strain was analyzed based on routine DICOM (Digital Imaging and Communications in Medicine) data sets using software (2D Cardiac Performance Analysis, TomTec, Munich, Germany). A region of interest was manually placed on the endocardial and epicardial borders. The echocardiographic data were gathered and analyzed by 2 experienced echocardiographers who were unaware of any corresponding clinical data.
Statistical analysis Data were reported as means and standard deviation (SD). For the comparison of means between groups, we used the Mann-Whitney test because the sample size was small (n=14 for each group).
All P values calculated are two-tailed and considered significant at P < 0.05. All statistical analysis was performed using SPSS 20.0 software (SPSS Inc, Chicago, USA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Differentiated thyroid cancer group: who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. 1) age less than 45 years old when receiving total or near-total thyroidectomy, 2) serum level of TSH<0.1 mU/L in the intermediate recurrence-risk or TSH<0.3 mU/L in the low recurrence-risk group13, 14 over 2 years before study entry, 3) receiving TSH suppressive therapy for 5 to 9 years with fixed dose of LT4 more than 2 years before study entry, and 4) no history of structural heart disease, arrhythmia, or cardiac symptoms (palpitation, exertional dyspnea and chest discomfort) during therapy. |
| Control | – | –Control group As each DTC patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension. |
Who may qualify
- Ages
- 32 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female differentiated thyroid cancer patients who received total- or near-total thyroidectomy, and thereafter regularly visited the endocrine out-patient department (OPD) of Chuncheon Sacred Heart Hospital. Finally, 14 DTC patients were enrolled and studied from September 2009 to March 2010. As each patient was enrolled, control subjects were selected from patients who visited endocrinology department for thyroid nodule work-up. All subjects who met the enrollment criteria took an electrocardiogram to rule out arrhythmias.
Key inclusion criteria (10 listed)
- thyroid cancer group
- control group
Key exclusion criteria (1 listed)
- who had arrhythmia in electrography or history of cardiac disease
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
comparison of cardiac fucntion and structure between groups
Time frame: measure cardiac function and struture at 2009 in case (DTC group) and at 2010 in control group
In DTC group, the investiagtors measured cardiac function and structure by echocardiography at 2009 (receiving TSH suppressive therapy for 5 to 9 years after thyroidectomy). As each DTC patient was enrolled, control subjects were selected from persons who visited endocrinology department for thyroid nodule work-up. The control group had to meet the following criteria: 1) the subject matched to a patient by age (±2 years), sex, and body mass index (BMI) (±2 kg/m2), 2) within the reference range of serum TSH (0.3-4.6 mU/L), 3) no history of structural heart disease, arrhythmia, or cardiac symptoms, 4) no history of comorbid diseases which affect thyroxine metabolism and cardiac structure, including hepatic or renal disease, anemia, and hypertension.The cardiac function and structure were evaluated by echocardiography at 2010.
3 secondary outcomes
comparison of heart rate between groups
Time frame: measure heart rate at 2009 in case (DTC group) and at 2010 in control group.
comparison of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) between groups
Time frame: measure NT-pro-BNP at 2009 in DTC group and at 2010 in control group
thyroid function test (TSH, free T4, free T3)
Time frame: comparison of thyroid function at 2009 in case (DTC) and 2010 in control group
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 5 Jan 2016.
- Derived from this study: PubMed 27418929Hong KS, Son JW, Ryu OH, Choi MG, Hong JY, Lee SJ. Cardiac Effects of Thyrotropin Oversuppression with Levothyroxine in Young Women with Differentiated Thyroid Cancer. Int J Endocrinol. 2016;2016:9846790. doi: 10.1155/2016/9846790. Epub 2016 Jun 23.
- Individual participant dataSharing planned: No. We have no plan to share the data with other investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of Thyroid and Heart Diseases, run by Chuncheon Sacred Heart Hospital.
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 10 inclusion and 1 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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
comparison of cardiac fucntion and structure between groups (time frame: measure cardiac function and struture at 2009 in case (DTC group) and at 2010 in control group). 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 NCT02645786, which also lists 1 linked publication.
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 5 Jan 2016.