Thyroid CancerThyroid cancerNCT01781767
Changes in Metabolic Status in Patients With Total Thyroidectomy
An observational study of Thyroid Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2) mRNA expression as function of thyroid activity (TSH, T3 and Free T4). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jul 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were diagnosed with thyroid carcinoma and are going throgh total thyroidectomy and recive a thyroid replacement therapy.
Who may be able to join
- Patients who were diagnosed with thyroid carcinoma and are going to have total thyroidectomy.
- Patients with unbalanced thyroid hormones.
- Aged 18-65 years at the time of screening.
- Provision of written informed consent.
Who cannot join
- Patients with Diabetes.
- Patients with any other chronic inflammatory diseases.
- Steroid treatment.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Nachum Vaisman, M.D., 972-3-6974807, vaisman@tasmc.health.gov.il
About this study
This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2) mRNA expression as function of thyroid activity (TSH, T3 and Free T4).
Read the detailed description
Blood will be drown before thyroidectomy, 2 weeks after the operation and 3-4 month after the operation.
- Conditions
- Thyroid Cancer
- Keywords
- UCP2, Thyroid function, Thyroid carcinoma
- Medical subject headings
- Thyroid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in UCP2 mRNA concentrations.
The difference between the result at two weeks and four months compare to base line.
Measured: Base line (before opporation), 2 weeks after opporation and for after opporation.
Secondary outcomes (2)
Weight
Measured: Approximately 4 months
Resting energy expenditure
Measured: Approximatly 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781767
- Sponsor's protocol ID
- TASMC-12-NV-376-CTIL
- Acronym
- Thyroid cancer
- Status last verified
- Jan 2013
- First submitted
- 27 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yen PM. Physiological and molecular basis of thyroid hormone action. Physiol Rev. 2001 Jul;81(3):1097-142. doi: 10.1152/physrev.2001.81.3.1097.
PubMed 11427693Schwartz HL, Oppenheimer JH. Physiologic and biochemical actions of thyroid hormone. Pharmacol Ther B. 1978;3(3):349-76. doi: 10.1016/s0306-039x(78)80002-6. No abstract available.
PubMed 203955Brand MD, Esteves TC. Physiological functions of the mitochondrial uncoupling proteins UCP2 and UCP3. Cell Metab. 2005 Aug;2(2):85-93. doi: 10.1016/j.cmet.2005.06.002.
PubMed 16098826Nicholls DG, Locke RM. Thermogenic mechanisms in brown fat. Physiol Rev. 1984 Jan;64(1):1-64. doi: 10.1152/physrev.1984.64.1.1. No abstract available.
PubMed 6320232Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.
PubMed 20427509
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Metabolic Status in Patients With Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT01781767
- Acronym / sponsor ID
- Thyroid cancer / TASMC-12-NV-376-CTIL
- Conditions
- Thyroid Cancer
- Keywords
- UCP2, Thyroid function, Thyroid carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 1 Feb 2013 (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.
This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2) mRNA expression as function of thyroid activity (TSH, T3 and Free T4).
Detailed description
Blood will be drown before thyroidectomy, 2 weeks after the operation and 3-4 month after the operation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with thyroid carcinoma and are going throgh total thyroidectomy and recive a thyroid replacement therapy.
Key inclusion criteria (4 listed)
- Patients who were diagnosed with thyroid carcinoma and are going to have total thyroidectomy.
- Patients with unbalanced thyroid hormones.
- Aged 18-65 years at the time of screening.
- Provision of written informed consent.
Key exclusion criteria (3 listed)
- Patients with Diabetes.
- Patients with any other chronic inflammatory diseases.
- Steroid treatment.
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
Changes in UCP2 mRNA concentrations.
Time frame: Base line (before opporation), 2 weeks after opporation and for after opporation.
The difference between the result at two weeks and four months compare to base line.
2 secondary outcomes
Weight
Time frame: Approximately 4 months
Resting energy expenditure
Time frame: Approximatly 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
- Background: PubMed 11427693Yen PM. Physiological and molecular basis of thyroid hormone action. Physiol Rev. 2001 Jul;81(3):1097-142. doi: 10.1152/physrev.2001.81.3.1097.
- Background: PubMed 203955Schwartz HL, Oppenheimer JH. Physiologic and biochemical actions of thyroid hormone. Pharmacol Ther B. 1978;3(3):349-76. doi: 10.1016/s0306-039x(78)80002-6. No abstract available.
- Background: PubMed 16098826Brand MD, Esteves TC. Physiological functions of the mitochondrial uncoupling proteins UCP2 and UCP3. Cell Metab. 2005 Aug;2(2):85-93. doi: 10.1016/j.cmet.2005.06.002.
- Background: PubMed 6320232Nicholls DG, Locke RM. Thermogenic mechanisms in brown fat. Physiol Rev. 1984 Jan;64(1):1-64. doi: 10.1152/physrev.1984.64.1.1. No abstract available.
- Background: PubMed 20427509Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.
Related trials for Thyroid Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Recruiting
Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
Thyroid Nodule (Diagnosis)
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
RecruitingPhase 2
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
Thyroid Cancer
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.
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 Thyroid Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, M.D. (972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in UCP2 mRNA concentrations. (time frame: Base line (before opporation), 2 weeks after opporation and for after opporation.). 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 NCT01781767, which also lists 5 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 1 Feb 2013.