Lipid Metabolic Status in Thyroid Carcinoma

NCT01487057 | Completed

• 1 other identifier: ChiricutaIO
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Carcinoma; Dyslipidemias; Risk Reduction Behavior; Hormone Replacement

Keywords

thyroid cancer; dislipidemia; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• hsCRP an inflammatory biomarker for cardiovascular risk

  hsCRP in thyroid hormone withdrwal for patients with thyroid carcinoma radically treated

  May 2012

Secondary Outcomes (1)

• hsCRP may increase in repeated thyroid hormone withdrawal

  May 2012

Other Outcomes (1)

• hsCRP related to thyroid hormone withdrawal in patients with thyroid carcinoma radically treated

  May 2012

Study Arms (2)

Thyroid cancer, lipids, LT4 withdrawal

Thyroid cancer, Lipids, LT4 substitution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will prospectively study a group of patients from the evidence of IOCN, with the histology of differentiated thyroid cancer, radically treated with total thyroidectomy, radioiodine therapy and undergoing chronic substitutive hormone treatment, levothyroxine. The evaluation of these patients will be done during the routine oncological control, after 6-12 months post therapy, while withdrawing the hormone treatment and inducing a short-term iatrogenic myxedema. We are estimating a total number of 30 patients with 3 successive determinations in 1 year. The ethics committee will evaluate this study and each patient will be included voluntarily, following clear information of the patient and an informed consent.

You may qualify if:

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

You may not qualify if:

• other causes of high CRP (infection, inflammation)

Sponsors & Collaborators

• Prof. Dr. I. Chiricuta Institute of Oncology: lead
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator

Study Sites (1)

Institute of Oncology "Prof.dr.I.Chiricuta"

Cluj-Napoca, Cluj, 400015, Romania

Location

Related Links

• Institute of Oncology "Prof.dr.i.Chiricuta"
• University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca

MeSH Terms

Conditions

Thyroid Neoplasms; Dyslipidemias; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Alexandru Irimie, PhD

  IOCN

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

RO (1)