Lipid Metabolic Status in Thyroid Carcinoma

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Brief Title

Lipid Metabolic Status in Thyroid Carcinoma

Official Title

"Evaluation of Lipid Metabolic Status and of Cardiovascular Risk at Patients With Thyroid Carcinoma, Radically Treated and With Chronic Thyroid Hormonal Substitution"

Brief Summary

      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.
    

Detailed Description

      Although considered a rare type of cancer with an incidence under 6 cases for 100 000
      persons, the thyroid carcinoma is the most frequent endocrine tumor. The incidence of this
      malignant disease has exponentially increased in the last decade, so that many specially
      centers in the world have focused on a better strategy of diagnosis, of treatment and of
      monitoring. By applying a suitable multimodal treatment, the prognosis of this disease is
      excellent, offering the patients a survival rate of over 90% at 10 years. During the
      monitoring of the disease, the patients are periodically supposed to withdraw the hormone
      treatment; because of this hormone imbalance, there will be important changes of the
      metabolism, especially the lipid one. This is the reason why we are preoccupied to increase
      the quality of life of the patients addicted to a chronic thyroid hormone therapy. The aim of
      this study is to demonstrate the way in which the lipid profile is influenced and to quantify
      the cardiovascular risk for the patients radically treated of thyroid cancer, by total
      thyroidectomy, metabolic irradiation and undergoing a chronic thyroid hormone treatment.
      Nowadays, Romania is one of the countries in which these patients are supposed to be kept in
      a iatrogenous myxoedema, the alternative being the recombinant thyroid stimulating hormone.
      For the patients with the mentioned diagnosis, the lipid profile will be determined and will
      consist of the following: total serologic cholesterol, cholesterol fractions, triglycerides
      and C reactive protein highly sensitive (hsCRP). A score for the cardiovascular accident risk
      will be elaborated. The attempt of classifying in cardiovascular risk groups the patients
      through the present study, would facilitate the selection of the patients and their access to
      therapies and modern monitoring strategies.
    


Study Type

Observational


Primary Outcome

hsCRP an inflammatory biomarker for cardiovascular risk

Secondary Outcome

 hsCRP may increase in repeated thyroid hormone withdrawal

Condition

Thyroid Carcinoma


Study Arms / Comparison Groups

 Thyroid cancer, lipids, LT4 withdrawal
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

52

Start Date

February 2011

Completion Date

May 2012

Primary Completion Date

February 2012

Eligibility Criteria

        Inclusion Criteria:

          -  thyroid carcinoma radically treated (surgery, radioiodine, thyroid hormone suppression
             )

        Exclusion Criteria:

          -  other causes of high CRP (infection, inflammation)
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Alexandru Irimie, PhD, , 

Location Countries

Romania

Location Countries

Romania

Administrative Informations


NCT ID

NCT01487057

Organization ID

ChiricutaIO


Responsible Party

Principal Investigator

Study Sponsor

Prof. Dr. I. Chiricuta Institute of Oncology

Collaborators

 Iuliu Hatieganu University of Medicine and Pharmacy

Study Sponsor

Alexandru Irimie, PhD, Study Director, IOCN


Verification Date

December 2012