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Thyroid Diseases clinical trials

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NCT ID: NCT01856920 Active, not recruiting - Clinical trials for Medullary Thyroid Cancer (MTC)

QUILT-3.006 for Recurrent Medullary Thyroid Cancer

Start date: March 7, 2013
Phase: Phase 2
Study type: Interventional

Background: - GI-6207 is an experimental cancer vaccine made with baker's yeast. The yeast has been modified to help the immune system target a protein called CEA. CEA is found on the surface of some kinds of tumor cells, including thyroid cancer cells. Researchers want to see if GI-6207 can encourage the body's immune system to attack and kill tumor cells that contain the CEA protein. They will test to see whether this vaccine is a safe and effective treatment for medullary thyroid cancer that has not responded to earlier treatments. Objectives: - To test the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid cancer. Eligibility: - Individuals at least 18 years of age who have medullary thyroid cancer that has not responded to earlier treatments. Design: - Participants will be screened with a physical exam and medical history. They will provide blood and tumor samples and have an imaging study of the neck and chest. They will also have a skin test to make sure that they are not allergic to the yeast in the vaccine. - Participants will be divided into two groups. One group will start to take GI-6207 immediately for 1 year. The second group will have 6 months of monitoring and tests with no vaccine, and then will take GI-6207 for 1 year. - GI-6207 will be given every other week for the first seven visits (about 3 months), and then monthly for the remaining year of treatment. It will be given as injections beneath the arm and in the upper thigh. These locations will help the vaccine enter the lymph nodes and reach the immune system more quickly. - Participants will be monitored with frequent blood and urine tests and imaging studies. - Participants will have regular follow-up visits after their year of study vaccines.

NCT ID: NCT01848171 Active, not recruiting - Hypothyroidism Clinical Trials

Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress. Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.

NCT ID: NCT01846364 Terminated - Clinical trials for Proliferative Thyroid Disease

DIM as a Treatment for Thyroid Disease

Start date: November 2006
Phase: Phase 0
Study type: Interventional

Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such as cabbage, cauliflower, broccoli, & Brussels sprouts) has been studied extensively in recent years for its anti-cancer effects. DIM has been shown to exert control over cancer cell growth in breast, uterine, cervical, ovarian, and colon cancer. To date no human study has been published regarding the bioavailability of DIM in thyroid tissue or its effects in proliferative thyroid disease. Our previous study attempted to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease and ascertain its uptake in thyroid tissue. DIM has been shown to concentrate in the thyroid gland. Furthermore, thyroid volumes have been seen to decrease subjectively. This study would continue our attempt to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease.

NCT ID: NCT01843062 Terminated - Clinical trials for Differentiated Thyroid Cancer

Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

ASTRA
Start date: August 27, 2013
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

NCT ID: NCT01840332 Completed - Thyroid Cancer Clinical Trials

Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Start date: April 2013
Phase: N/A
Study type: Interventional

The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.

NCT ID: NCT01838642 Terminated - Thyroid Neoplasms Clinical Trials

Ponatinib for Advanced Medullary Thyroid Cancer

Start date: March 2013
Phase: Phase 2
Study type: Interventional

Background: - Medullary thyroid cancer (MTC) represents 5% of thyroid cancers and presents as a hereditary (25% of cases) or sporadic (75% of cases) neuroendocrine malignancy. - MTC arises from the parafollicular C-cells of the thyroid. - Germline mutations in the rearranged during transfection (RET) proto-oncogene occur in virtually all of hereditary MTC cases, and somatic RET mutations occur in 50% of sporadic cases. - Drugs targeting RET kinase such as vandetanib and cabozantinib have shown efficacy in the treatment of advanced or metastatic MTC, however, more effective RET inhibitors are needed for previously untreated patients as well as patients who have become refractory to other molecular targeted therapeutics (MTTs). - Ponatinib, a drug that is Food and Drug Administration (FDA) approved as a therapy for chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is a potent inhibitor of RET kinase. Primary Objective: -To determine the objective overall response rate (complete response [CR] + partial response [PR] by Response Evaluation Criteria in Solid Tumors (RECIST) to ponatinib in the treatment of patients with advanced or metastatic MTC previously treated with cabozantinib and vandetanib who: 1) have tumors with RET mutations and 2) have tumors without RET mutations. Eligibility: - Patients must have histologically confirmed, unresectable, locally advanced or metastatic MTC, with measurable disease by RECIST criteria. - Patients must have disease amenable to biopsy and be willing to undergo biopsy for molecular analysis, and also have adequate archival material from their thyroidectomy or from a tumor biopsy obtained prior to beginning any systemic therapy. - Patients must have failed or been intolerant to prior treatment with both cabozantinib and vandetanib. - The last dose of prior systemic therapy must be more than 28 days prior to the first dose of ponatinib - Radiation therapy is permitted if the last treatment was received more than 28 days prior to the first dose of ponatinib. Design: - Open label phase II trial with 2 treatment groups: - RET mutation positive MTC, previously treated with vandetanib and cabozantinib - RET mutation negative MTC, previously treated with vandetanib and cabozantinib - Patients will receive ponatinib 30 mg orally daily until disease progression or until the development of intolerable side effects. - Tumor response will be assessed by RECIST 1.1 criteria at 8 weeks and then every 12 weeks thereafter. After one year on study, tumor response will be assessed every 16 weeks. - Patients will have a biopsy of their MTC for molecular analysis prior to initiating treatment with ponatinib. Patients will also have a biopsy of their MTC at the time of tumor progression, should that occur.

NCT ID: NCT01838031 Completed - Clinical trials for Subclinical Hypothyroidism

Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study

Start date: September 2011
Phase: N/A
Study type: Interventional

Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.

NCT ID: NCT01837745 Active, not recruiting - Clinical trials for Low Risk Differentiated Thyroid Cancer

Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

ESTIMABL2
Start date: May 13, 2013
Phase: Phase 3
Study type: Interventional

Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group). The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)

NCT ID: NCT01833650 Completed - Thyroid Cancer Clinical Trials

The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the use of honey mouthwashes in the prevention of salivary side effects of 131I (radioiodine) therapy.

NCT ID: NCT01831869 Active, not recruiting - Hypothyroidism Clinical Trials

Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.