- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487057
Lipid Metabolic Status in Thyroid Carcinoma (LITCA)
"Evaluation of Lipid Metabolic Status and of Cardiovascular Risk at Patients With Thyroid Carcinoma, Radically Treated and With Chronic Thyroid Hormonal Substitution"
The continuous increase of the incidence of the thyroid cancer in the last years has taken this neoplasia among the first 4 frequent cancers in the cancer registry of the Institute of Oncology "Prof.Ion Chiricuţă" from Cluj-Napoca (IOCN), with a total number of over 470 new cases per year, added to the other 3700 cases already being in the evidence of the Institute.
The radical treatment brings for a long term a compensated chronic drug induces mYxoedema with it's important side effects. Among these one can find the dislipidemia and the change of the high sensitive C reactive protein (hsCRP) serological value. In the last years, many epidemiological studies have confirmed the fact that the patients with a high serological value of the hsCRP present a higher risk for the coronary disease and heart attack.
Prospective studies developed in european countries and in USA have provided results that are related to the predictive value of the hsCRP determinations over the cardiovascular risk. Thus, hsCRP is an indirect risk factor for the coronary disease. The risk for cardiovascular disease is 2 to 7 times higher at the people with a high level of hsCRP comparing to ones with low levels; the increase of the hsCRP serological value can be determined several years before the clinical debut of the coronary disease.
The screening for this population group with a high risk can introduce in use the prevention of the cardiac pathology and change the approach to the monitoring of the patients with thyroid cancer. A selection protocol will be elaborated for the patients that will withdraw the hormone treatment by using recombinant thyroid stimulating hormone (TSH) or will have personalised monitoring algorithm, with a shortening of the hormone treatment withdrawal.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cluj
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Cluj-Napoca, Cluj, Romania, 400015
- Institute of Oncology "Prof.dr.I.Chiricuta"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- thyroid carcinoma radically treated (surgery, radioiodine, thyroid hormone suppression )
Exclusion Criteria:
- other causes of high CRP (infection, inflammation)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Thyroid cancer, lipids, LT4 withdrawal
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Thyroid cancer, Lipids, LT4 substitution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hsCRP an inflammatory biomarker for cardiovascular risk
Time Frame: May 2012
|
hsCRP in thyroid hormone withdrwal for patients with thyroid carcinoma radically treated
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May 2012
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hsCRP may increase in repeated thyroid hormone withdrawal
Time Frame: May 2012
|
May 2012
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hsCRP related to thyroid hormone withdrawal in patients with thyroid carcinoma radically treated
Time Frame: May 2012
|
May 2012
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Alexandru Irimie, PhD, IOCN
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChiricutaIO
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