Thyroid CarcinomaLITCANCT01487057
Lipid Metabolic Status in Thyroid Carcinoma
An observational study of Thyroid Carcinoma and Dyslipidemias, run by Prof. Dr. I. Chiricuta Institute of Oncology at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Carcinoma, Dyslipidemias, Risk Reduction Behavior
- How many people
- 52 participants
- Where
- 1 siteRomania
- Study dates
- Feb 2011to May 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- thyroid carcinoma radically treated (surgery, radioiodine, thyroid hormone suppression )
Who cannot join
- other causes of high CRP (infection, inflammation)
Trial locations and contacts
1 site in 1 country.
Romania1 site
Institute of Oncology "Prof.dr.I.Chiricuta"
Cluj-Napoca, Cluj, 400015
About this study
Official title: "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.
Read more
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.
Read the 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.
- Keywords
- thyroid cancer, dislipidemia, cardiovascular risk
- Medical subject headings
- Thyroid Neoplasms, Dyslipidemias, Risk Reduction Behavior
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 |
|---|---|---|
| Thyroid cancer, lipids, LT4 withdrawal | Not described | |
| Thyroid cancer, Lipids, LT4 substitution | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP an inflammatory biomarker for cardiovascular risk
hsCRP in thyroid hormone withdrwal for patients with thyroid carcinoma radically treated
Measured: May 2012
Secondary outcomes (1)
hsCRP may increase in repeated thyroid hormone withdrawal
Measured: May 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. I. Chiricuta Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy
- Responsible party
- Principal investigator, PICIU DOINA, Prof. Dr. I. Chiricuta Institute of Oncology
- Investigators
- Alexandru Irimie, PhD, Study director, IOCN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487057
- Sponsor's protocol ID
- ChiricutaIO
- Acronym
- LITCA
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2011
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Lipid Metabolic Status and of Cardiovascular Risk at Patients With Thyroid Carcinoma, Radically Treated and With Chronic Thyroid Hormonal Substitution"
- ClinicalTrials.gov ID
- NCT01487057
- Acronym / sponsor ID
- LITCA / ChiricutaIO
- Keywords
- thyroid cancer, dislipidemia, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Prof. Dr. I. Chiricuta Institute of OncologyUniversity, hospital or other
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Dec 2011 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid cancer, lipids, LT4 withdrawal | – | – |
| Thyroid cancer, Lipids, LT4 substitution | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- thyroid carcinoma radically treated (surgery, radioiodine, thyroid hormone suppression )
Key exclusion criteria (1 listed)
- other causes of high CRP (infection, inflammation)
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
hsCRP an inflammatory biomarker for cardiovascular risk
Time frame: May 2012
hsCRP in thyroid hormone withdrwal for patients with thyroid carcinoma radically treated
1 secondary outcome
hsCRP may increase in repeated thyroid hormone withdrawal
Time frame: May 2012
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 27 Dec 2012.
- Institute of Oncology "Prof.dr.i.Chiricuta"Link provided by the sponsor.
- University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-NapocaLink provided by the sponsor.
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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.
Alexandru Irimie, PhD study director
IOCN
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 Carcinoma and Dyslipidemias, run by Prof. Dr. I. Chiricuta Institute of Oncology at 1 site in Romania.
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 1 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 27 Dec 2012. 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 Romania. 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?
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?
hsCRP an inflammatory biomarker for cardiovascular risk (time frame: May 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2012.